Class 1 Device Recall Cobalt

• Date Initiated by Firm: June 22, 2022
• Date Posted: August 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1487-2022
• Recall Event ID: 90565
• PMA Number: P980016S713
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
• Code Information: a. Model Numbers: DVPB3D1: GTIN 00763000178499, Serial Numbers: RSE600212S, RSE600229S, RSE600406S, RSE600450S, RSE600505S, RSE600518S, RSE600519S, RSE600520S, RSE600538S, RSE600539S, RSE600621S, RSE600676S, RSE600681S, RSE600709S, RSE600715S, RSE600716S, RSE600717S, RSE600718S, RSE600725S, RSE600748S, RSE600756S, RSE600768S, RSE601500S, RSE601523S, RSE601579S, RSE601590S, RSE601603S, RSE601702S, RSE601705S, RSE601716S, RSE601718S, RSE601729S, RSE601746S, RSE601747S, RSE601768S, RSE601774S, RSE601780S, RSE601791S, RSE601802S, RSE601819S, RSE601828S, RSE601835S, RSE601841S, RSE601846S, RSE601857S, RSE601879S, RSE601885S, RSE601889S, RSE601890S, RSE601894S, RSE601899S, RSE601900S, RSE601906S, RSE601910S, RSE601914S, RSE601930S, RSE601935S, RSE601936S, RSE601937S, RSE601939S, RSE601940S, RSE601941S, RSE601945S, RSE601947S, RSE601952S, RSE601959S, RSE601965S, RSE602046S, RSE602047S, RSE602048S, RSE602049S, RSE602053S, RSE602060S, RSE602063S, RSE602064S, RSE602067S, RSE602081S, RSE602086S, RSE602087S, RSE602090S, RSE602092S, RSE602097S, RSE602111S, RSE602112S, RSE602123S, RSE602126S, RSE602139S, RSE602144S, RSE602145S, RSE602146S, RSE602147S, RSE602148S, RSE602149S, RSE602151S, RSE602154S, RSE602165S, RSE602166S, RSE602167S, RSE602169S, RSE602180S, RSE602181S, RSE602186S, RSE602189S, RSE602190S, RSE602191S, RSE602192S, RSE602196S, RSE602198S, RSE602200S, RSE602202S, RSE602203S, RSE602212S, RSE602214S, RSE602215S, RSE602240S, RSE602241S, RSE602244S, RSE602249S, RSE602250S, RSE602252S, RSE602258S, RSE602259S, RSE602260S, RSE602261S, RSE602265S, RSE602267S, RSE602268S, RSE602270S, RSE602273S, RSE602274S, RSE602275S, RSE602278S, RSE602289S, RSE602295S, RSE602298S, RSE602299S, RSE602300S, RSE602301S, RSE602306S, RSE602312S, RSE602316S, RSE602323S, RSE602324S, RSE602325S, RSE602326S, RSE602328S; GTIN 00763000178505, Serial Numbers: RSE600007S, RSE600009S, RSE600011S, RSE600012S, RSE600014S, RSE600015S, RSE600016S, RSE600017S, RSE600019S, RSE600020S, RSE600023S, RSE600024S, RSE600025S, RSE600028S, RSE600030S, RSE600033S, RSE600034S, RSE600036S, RSE600041S, RSE600042S, RSE600044S, RSE600046S, RSE600048S, RSE600049S, RSE600053S, RSE600054S, RSE600059S, RSE600060S, RSE600062S, RSE600067S, RSE600068S, RSE600069S, RSE600071S, RSE600072S, RSE600073S, RSE600075S, RSE600076S, RSE600077S, RSE600079S, RSE600080S, RSE600086S, RSE600090S, RSE600091S, RSE600092S, RSE600093S, RSE600094S, RSE600168S, RSE600559S, RSE600679S, RSE600683S, RSE600772S, RSE600874S, RSE601010S, RSE601013S, RSE601160S, RSE601161S, RSE601162S, RSE601163S, RSE601165S, RSE601166S, RSE601167S, RSE601169S, RSE601170S, RSE601171S, RSE601172S, RSE601173S, RSE601175S, RSE601177S, RSE601178S, RSE601179S, RSE601180S, RSE601181S, RSE601182S, RSE601183S, RSE601184S, RSE601185S, RSE601187S, RSE601189S, RSE601192S, RSE601193S, RSE601194S, RSE601196S, RSE601199S, RSE601202S, RSE601210S, RSE601211S, RSE601212S, RSE601214S, RSE601215S, RSE601217S, RSE601218S, RSE601219S, RSE601220S, RSE601221S, RSE601228S, RSE601230S, RSE601237S, RSE601239S, RSE601240S, RSE601242S, RSE601244S, RSE601247S, RSE601248S, RSE601250S, RSE601252S, RSE601255S, RSE601260S, RSE601262S, RSE601263S, RSE601267S, RSE601268S, RSE601274S, RSE601275S, RSE601276S, RSE601277S, RSE601278S, RSE601279S, RSE601280S, RSE601281S, RSE601282S, RSE601283S, RSE601284S, RSE601285S, RSE601286S, RSE601287S, RSE601289S, RSE601290S, RSE601293S, RSE601294S, RSE601297S, RSE601298S, RSE601301S, RSE601302S, RSE601303S, RSE601304S, RSE601310S, RSE601326S, RSE601340S, RSE601346S, RSE601347S, RSE601356S, RSE601360S, RSE601362S, RSE601363S, RSE601369S, RSE601398S, RSE601400S, RSE601401S, RSE601403S, RSE601404S, RSE601405S, RSE601408S, RSE601409S, RSE601412S, RSE601413S, RSE601414S, RSE601416S, RSE601417S, RSE601418S, RSE601420S, RSE601421S, RSE601422S, RSE601423S, RSE601433S, RSE601437S, RSE601438S, RSE601440S, RSE601441S, RSE601447S, RSE601448S, RSE601449S, RSE601450S, RSE601470S, RSE601472S, RSE601482S, RSE601483S, RSE601488S, RSE601812S, RSE601813S, RSE601814S, RSE601815S, RSE601816S, RSE601817S, RSE601820S, RSE601831S, RSE601833S, RSE601837S, RSE601854S, RSE601858S, RSE601859S, RSE601861S, RSE601867S, RSE601875S, RSE601938S, RSE601968S, RSE601969S, RSE601970S, RSE601971S, RSE601992S, RSE601994S, RSE601995S, RSE601996S, RSE601997S, RSE601998S, RSE601999S, RSE602000S, RSE602001S, RSE602002S, RSE602004S, RSE602005S, RSE602006S, RSE602008S, RSE602009S, RSE602010S, RSE602011S, RSE602012S, RSE602013S, RSE602014S, RSE602015S, RSE602016S, RSE602018S, RSE602019S, RSE602021S, RSE602022S, RSE602023S, RSE602026S, RSE602027S, RSE602028S, RSE602029S, RSE602030S, RSE602031S, RSE602032S, RSE602033S, RSE602036S, RSE602038S, RSE602040S, RSE602041S, RSE602042S, RSE602043S, RSE602044S, RSE602045S, RSE602052S, RSE602057S, RSE602058S, RSE602059S, RSE602061S, RSE602065S, RSE602205S, RSE602208S, RSE602216S, RSE602217S, RSE602219S, RSE602220S, RSE602221S, RSE602222S, RSE602223S, RSE602224S, RSE602225S, RSE602226S, RSE602227S, RSE602228S, RSE602229S, RSE602231S, RSE602232S, RSE602233S, RSE602234S, RSE602235S, RSE602257S, RSE602263S, RSE602269S, RSE602276S, RSE602283S, RSE602286S, RSE602288S, RSE602290S, RSE602304S, RSE602309S, RSE602320S, RSE602321S, RSE602327S, RSE602330S, RSE602331S, RSE602332S, RSE602334S, RSE602337S, RSE602343S, RSE602354S; DVPB3D4: GTIN 00763000178512, Serial Numbers: RSF600173S, RSF601052S, RSF601153S, RSF601202S, RSF601346S, RSF601408S, RSF601414S, RSF601420S, RSF601421S, RSF601428S, RSF601564S, RSF601585S, RSF602664S, RSF602685S, RSF602807S, RSF602911S, RSF602915S, RSF602917S, RSF602937S, RSF602996S, RSF603382S, RSF603499S, RSF603500S, RSF603529S, RSF603631S, RSF604041S, RSF604048S, RSF604060S, RSF604100S, RSF604102S, RSF604106S, RSF604157S, RSF604163S, RSF604172S, RSF604190S, RSF604192S, RSF604210S, RSF604214S, RSF604218S, RSF604220S, RSF604223S, RSF604437S, RSF604439S, RSF604480S, RSF604483S, RSF604487S, RSF604574S, RSF604575S, RSF604578S, RSF604579S, RSF604581S, RSF604588S, RSF604590S, RSF604592S, RSF604593S, RSF604625S, RSF604627S, RSF604630S, RSF604654S, RSF604663S, RSF604665S, RSF604705S, RSF604715S, RSF604716S, RSF604755S, RSF604768S, RSF604776S, RSF604854S, RSF604881S, RSF604892S, RSF604982S, RSF605070S, RSF605071S, RSF605072S, RSF605073S, RSF605083S, RSF605092S, RSF605095S, RSF605099S, RSF605105S, RSF605108S, RSF605109S, RSF605110S, RSF605111S, RSF605112S, RSF605113S, RSF605114S, RSF605118S; GTIN 00763000178529, Serial Numbers: RSF600008S, RSF600009S, RSF600011S, RSF600013S, RSF600014S, RSF600016S, RSF600017S, RSF600018S, RSF600019S, RSF600020S, RSF600021S, RSF600022S, RSF600023S, RSF600024S, RSF600025S, RSF600026S, RSF600027S, RSF600028S, RSF600029S, RSF600030S, RSF600031S, RSF600032S, RSF600033S, RSF600034S, RSF600035S, RSF600036S, RSF600037S, RSF600038S, RSF600039S, RSF600041S, RSF600042S, RSF600043S, RSF600044S, RSF600045S, RSF600048S, RSF600050S, RSF600051S, RSF600052S, RSF600055S, RSF600057S, RSF600058S, RSF600059S, RSF600060S, RSF600061S, RSF600062S, RSF600064S, RSF600065S, RSF600066S, RSF600067S, RSF600068S, RSF600069S, RSF600070S, RSF600071S, RSF600072S, RSF600073S, RSF600074S, RSF600076S, RSF600077S, RSF600078S, RSF600079S, RSF600080S, RSF600081S, RSF600082S, RSF600084S, RSF600085S, RSF600086S, RSF600092S, RSF600093S, RSF600097S, RSF600098S, RSF600099S, RSF600100S, RSF600101S, RSF600102S, RSF600103S, RSF600104S, RSF600105S, RSF600106S, RSF600107S, RSF600108S, RSF600109S, RSF600110S, RSF600111S, RSF600112S, RSF600113S, RSF600114S, RSF600117S, RSF600118S, RSF600119S, RSF600120S, RSF600121S, RSF600122S, RSF600124S, RSF600126S, RSF600128S, RSF600129S, RSF600131S, RSF600132S, RSF600134S, RSF600136S, RSF600137S, RSF600138S, RSF600139S, RSF600141S, RSF600144S, RSF600145S, RSF600688S, RSF601187S, RSF601205S, RSF601349S, RSF601407S, RSF601423S, RSF601425S, RSF601426S, RSF601450S, RSF601453S, RSF601459S, RSF601461S, RSF601543S, RSF601544S, RSF601865S, RSF601867S, RSF601868S, RSF601871S, RSF601873S, RSF601874S, RSF601877S, RSF601882S, RSF601884S, RSF602003S, RSF602004S, RSF602005S, RSF602006S, RSF602007S, RSF602008S, RSF602009S, RSF602010S, RSF602011S, RSF602012S, RSF602013S, RSF602014S, RSF602015S, RSF602016S, RSF602017S, RSF602018S, RSF602019S, RSF602020S, RSF602021S, RSF602022S, RSF602024S, RSF602025S, RSF602026S, RSF602027S, RSF602028S, RSF602029S, RSF602030S, RSF602031S, RSF602032S, RSF602033S, RSF602034S, RSF602035S, RSF602036S, RSF602037S, RSF602038S, RSF602039S, RSF602040S, RSF602041S, RSF602042S, RSF602043S, RSF602044S, RSF602045S, RSF602046S, RSF602047S, RSF602048S, RSF602049S, RSF602050S, RSF602051S, RSF602052S, RSF602053S, RSF602054S, RSF602055S, RSF602056S, RSF602057S, RSF602058S, RSF602059S, RSF602060S, RSF602061S, RSF602062S, RSF602063S, RSF602064S, RSF602065S, RSF602066S, RSF602067S, RSF602068S, RSF602069S, RSF602070S, RSF602071S, RSF602072S, RSF602073S, RSF602074S, RSF602075S, RSF602076S, RSF602077S, RSF602078S, RSF602079S, RSF602080S, RSF602081S, RSF602082S, RSF602083S, RSF602084S, RSF602086S, RSF602087S, RSF602088S, RSF602089S, RSF602090S, RSF602091S, RSF602092S, RSF602093S, RSF602094S, RSF602095S, RSF602096S, RSF602097S, RSF602098S, RSF602099S, RSF602100S, RSF602101S, RSF602102S, RSF602103S, RSF602104S, RSF602105S, RSF602106S, RSF602107S, RSF602108S, RSF602109S, RSF602110S, RSF602111S, RSF602112S, RSF602113S, RSF602114S, RSF602115S, RSF602116S, RSF602117S, RSF602118S, RSF602119S, RSF602120S, RSF602121S, RSF602122S, RSF602123S, RSF602124S, RSF602125S, RSF602126S, RSF602127S, RSF602128S, RSF602129S, RSF602130S, RSF602131S, RSF602132S, RSF602133S, RSF602134S, RSF602135S, RSF602136S, RSF602137S, RSF602138S, RSF602139S, RSF602140S, RSF602141S, RSF602142S, RSF602143S, RSF602144S, RSF602145S, RSF602146S, RSF602147S, RSF602148S, RSF602149S, RSF602150S, RSF602151S, RSF602152S, RSF602153S, RSF602154S, RSF602155S, RSF602156S, RSF602157S, RSF602158S, RSF602162S, RSF602166S, RSF602170S, RSF602171S, RSF602172S, RSF602175S, RSF602178S, RSF602180S, RSF602182S, RSF602183S, RSF602184S, RSF602185S, RSF602188S, RSF602190S, RSF602191S, RSF602192S, RSF602193S, RSF602194S, RSF602195S, RSF602196S, RSF602197S, RSF602200S, RSF602202S, RSF602203S, RSF602204S, RSF602206S, RSF602209S, RSF602210S, RSF602211S, RSF602214S, RSF602218S, RSF602219S, RSF602222S, RSF602223S, RSF602224S, RSF602225S, RSF602226S, RSF602227S, RSF602228S, RSF602229S, RSF602230S, RSF602231S, RSF602232S, RSF602233S, RSF602235S, RSF602236S, RSF602237S, RSF602238S, RSF602239S, RSF602240S, RSF602241S, RSF602242S, RSF602243S, RSF602244S, RSF602245S, RSF602247S, RSF602248S, RSF602249S, RSF602250S, RSF602251S, RSF602252S, RSF602254S, RSF602255S, RSF602256S, RSF602257S, RSF602258S, RSF602259S, RSF602260S, RSF602263S, RSF602264S, RSF602266S, RSF602268S, RSF602270S, RSF602271S, RSF602272S, RSF602273S, RSF602274S, RSF602276S, RSF602278S, RSF602279S, RSF602280S, RSF602281S, RSF602282S, RSF602283S, RSF602284S, RSF602286S, RSF602287S, RSF602288S, RSF602289S, RSF602290S, RSF602291S, RSF602295S, RSF602296S, RSF602298S, RSF602300S, RSF602301S, RSF602302S, RSF602303S, RSF602304S, RSF602305S, RSF602306S, RSF602307S, RSF602308S, RSF602309S, RSF602310S, RSF602311S, RSF602312S, RSF602313S, RSF602314S, RSF602315S, RSF602316S, RSF602318S, RSF602319S, RSF602321S, RSF602322S, RSF602323S, RSF602324S, RSF602328S, RSF602330S, RSF602331S, RSF602332S, RSF602333S, RSF602335S, RSF602336S, RSF602337S, RSF602338S, RSF602340S, RSF602342S, RSF602344S, RSF602346S, RSF602348S, RSF602351S, RSF602358S, RSF602361S, RSF602362S, RSF602363S, RSF602366S, RSF602368S, RSF602370S, RSF602374S, RSF602376S, RSF602378S, RSF602379S, RSF602382S, RSF602384S, RSF602387S, RSF602388S, RSF602389S, RSF602390S, RSF602391S, RSF602394S, RSF602405S, RSF602408S, RSF602409S, RSF602417S, RSF602418S, RSF602419S, RSF602420S, RSF602421S, RSF602422S, RSF602426S, RSF602431S, RSF602436S, RSF602438S, RSF602442S, RSF602443S, RSF602445S, RSF602446S, RSF602447S, RSF602448S, RSF602450S, RSF602451S, RSF602453S, RSF602454S, RSF602455S, RSF602456S, RSF602458S, RSF602459S, RSF602460S, RSF602465S, RSF602469S, RSF602470S, RSF602471S, RSF602473S, RSF602474S, RSF602475S, RSF602477S, RSF602478S, RSF602480S, RSF602481S, RSF602482S, RSF602483S, RSF602484S, RSF602485S, RSF602489S, RSF602491S, RSF602493S, RSF602495S, RSF602496S, RSF602498S, RSF602500S, RSF602502S, RSF602506S, RSF602507S, RSF602508S, RSF602509S, RSF602514S, RSF602516S, RSF602523S, RSF602528S, RSF602530S, RSF602531S, RSF602532S, RSF602533S, RSF602540S, RSF602543S, RSF602894S, RSF602898S, RSF602899S, RSF602943S, RSF602944S, RSF602945S, RSF602946S, RSF602948S, RSF602949S, RSF602950S, RSF602956S, RSF602977S, RSF602994S, RSF602997S, RSF602999S, RSF603006S, RSF603007S, RSF603008S, RSF603009S, RSF603014S, RSF603015S, RSF603016S, RSF603037S, RSF603055S, RSF603061S, RSF603064S, RSF603072S, RSF603073S, RSF603074S, RSF603078S, RSF603079S, RSF603080S, RSF603082S, RSF603083S, RSF603158S, RSF603159S, RSF603160S, RSF603161S, RSF603162S, RSF603164S, RSF603167S, RSF603169S, RSF603171S, RSF603172S, RSF603174S, RSF603180S, RSF603188S, RSF603195S, RSF603197S, RSF603198S, RSF603200S, RSF603202S, RSF603203S, RSF603204S, RSF603205S, RSF603206S, RSF603208S, RSF603209S, RSF603211S, RSF603212S, RSF603215S, RSF603217S, RSF603219S, RSF603228S, RSF603230S, RSF603232S, RSF603236S, RSF603237S, RSF603239S, RSF603243S, RSF603246S, RSF603252S, RSF603253S, RSF603257S, RSF603258S, RSF603264S, RSF603267S, RSF603269S, RSF603270S, RSF603272S, RSF603275S, RSF603277S, RSF603279S, RSF603280S, RSF603281S, RSF603282S, RSF603283S, RSF603284S, RSF603285S, RSF603286S, RSF603287S, RSF603288S, RSF603289S, RSF603290S, RSF603291S, RSF603292S, RSF603293S, RSF603294S, RSF603295S, RSF603296S, RSF603297S, RSF603298S, RSF603299S, RSF603300S, RSF603301S, RSF603302S, RSF603303S, RSF603304S, RSF603305S, RSF603306S, RSF603307S, RSF603308S, RSF603309S, RSF603310S, RSF603311S, RSF603312S, RSF603313S, RSF603314S, RSF603315S, RSF603316S, RSF603317S, RSF603318S, RSF603319S, RSF603321S, RSF603322S, RSF603323S, RSF603324S, RSF603325S, RSF603326S, RSF603327S, RSF603328S, RSF603329S, RSF603330S, RSF603331S, RSF603332S, RSF603333S, RSF603334S, RSF603335S, RSF603336S, RSF603337S, RSF603338S, RSF603339S, RSF603340S, RSF603341S, RSF603342S, RSF603343S, RSF603344S, RSF603345S, RSF603346S, RSF603347S, RSF603348S, RSF603563S, RSF603805S, RSF603816S, RSF603839S, RSF603841S, RSF603844S, RSF603846S, RSF603847S, RSF603848S, RSF603850S, RSF603853S, RSF603895S, RSF603912S, RSF603913S, RSF603914S, RSF603915S, RSF603925S, RSF603927S, RSF603929S, RSF603931S, RSF603937S, RSF603941S, RSF603980S, RSF603981S, RSF603983S, RSF603984S, RSF604000S, RSF604002S, RSF604005S, RSF604006S, RSF604015S, RSF604016S, RSF604035S, RSF604038S, RSF604039S, RSF604040S, RSF604043S, RSF604044S, RSF604045S, RSF604047S, RSF604051S, RSF604058S, RSF604065S, RSF604079S, RSF604081S, RSF604083S, RSF604084S, RSF604086S, RSF604095S, RSF604101S, RSF604294S, RSF604295S, RSF604296S, RSF604297S, RSF604298S, RSF604300S, RSF604301S, RSF604303S, RSF604305S, RSF604306S, RSF604307S, RSF604308S, RSF604309S, RSF604311S, RSF604312S, RSF604313S, RSF604314S, RSF604315S, RSF604317S, RSF604320S, RSF604321S, RSF604324S, RSF604328S, RSF604331S, RSF604332S, RSF604333S, RSF604334S, RSF604335S, RSF604336S, RSF604343S, RSF604345S, RSF604346S, RSF604347S, RSF604348S, RSF604349S, RSF604350S, RSF604351S, RSF604353S, RSF604354S, RSF604355S, RSF604356S, RSF604357S, RSF604360S, RSF604361S, RSF604362S, RSF604363S, RSF604364S, RSF604365S, RSF604366S, RSF604367S, RSF604368S, RSF604369S, RSF604371S, RSF604372S, RSF604373S, RSF604377S, RSF604378S, RSF604379S, RSF604380S, RSF604386S, RSF604392S, RSF604393S, RSF604395S, RSF604396S, RSF604397S, RSF604402S, RSF604403S, RSF604404S, RSF604405S, RSF604406S, RSF604407S, RSF604408S, RSF604410S, RSF604411S, RSF604412S, RSF604415S, RSF604416S, RSF604417S, RSF604418S, RSF604420S, RSF604422S, RSF604423S, RSF604427S, RSF604432S, RSF604434S, RSF604435S, RSF604441S, RSF604444S, RSF604447S, RSF604451S, RSF604453S, RSF604457S, RSF604462S, RSF604465S, RSF604467S, RSF604478S, RSF604484S, RSF604491S, RSF604494S, RSF604498S, RSF604499S, RSF604503S, RSF604504S, RSF604505S, RSF604506S, RSF604508S, RSF604509S, RSF604510S, RSF604511S, RSF604512S, RSF604513S, RSF604514S, RSF604515S, RSF604516S, RSF604517S, RSF604518S, RSF604519S, RSF604521S, RSF604522S, RSF604523S, RSF604524S, RSF604525S, RSF604526S, RSF604527S, RSF604528S, RSF604529S, RSF604530S, RSF604531S, RSF604532S, RSF604533S, RSF604534S, RSF604535S, RSF604536S, RSF604537S, RSF604538S, RSF604539S, RSF604540S, RSF604541S, RSF604542S, RSF604543S, RSF604544S, RSF604545S, RSF604546S, RSF604547S, RSF604548S, RSF604549S, RSF604550S, RSF604551S, RSF604552S, RSF604553S, RSF604555S, RSF604556S, RSF604557S, RSF604558S, RSF604559S, RSF604560S, RSF604561S, RSF604562S, RSF604563S, RSF604564S, RSF604565S, RSF604566S, RSF604567S, RSF604568S, RSF604569S, RSF604570S, RSF604571S, RSF604576S, RSF604577S, RSF604580S, RSF604583S, RSF604586S, RSF604587S, RSF604589S, RSF604596S, RSF604599S, RSF604605S, RSF604607S, RSF604617S, RSF604623S, RSF604624S, RSF604626S, RSF604629S, RSF604636S, RSF604638S, RSF604640S, RSF604642S, RSF604653S, RSF604683S, RSF604687S, RSF604691S, RSF604692S, RSF604694S, RSF604699S, RSF604702S, RSF604703S, RSF604704S, RSF604708S, RSF604710S, RSF604712S, RSF604719S, RSF604721S, RSF604722S, RSF604725S, RSF604727S, RSF604729S, RSF604731S, RSF604732S, RSF604734S, RSF604735S, RSF604736S, RSF604738S, RSF604739S, RSF604740S, RSF604742S, RSF604743S, RSF604745S, RSF604747S, RSF604750S, RSF604753S, RSF604754S, RSF604756S, RSF604757S, RSF604760S, RSF604761S, RSF604771S, RSF604779S, RSF604780S, RSF604781S, RSF604782S, RSF604783S, RSF604784S, RSF604785S, RSF604791S, RSF604794S, RSF604797S, RSF604798S, RSF604799S, RSF604800S, RSF604801S, RSF604802S, RSF604803S, RSF604804S, RSF604807S, RSF604808S, RSF604809S, RSF604810S, RSF604811S, RSF604812S, RSF604813S, RSF604815S, RSF604816S, RSF604817S, RSF604818S, RSF604819S, RSF604820S, RSF604824S, RSF604825S, RSF604827S, RSF604829S, RSF604830S, RSF604832S, RSF604834S, RSF604840S, RSF604844S, RSF604846S, RSF604848S, RSF604849S, RSF604851S, RSF604852S, RSF604853S, RSF604857S, RSF604858S, RSF604859S, RSF604860S, RSF604862S, RSF604866S, RSF604867S, RSF604869S, RSF604870S, RSF604871S, RSF604872S, RSF604873S, RSF604874S, RSF604875S, RSF604876S, RSF604877S, RSF604878S, RSF604879S, RSF604880S, RSF604882S, RSF604884S, RSF604887S, RSF604888S, RSF604891S, RSF604895S, RSF604897S, RSF604899S, RSF604902S, RSF604907S, RSF604909S, RSF604911S, RSF604912S, RSF604913S, RSF604914S, RSF604915S, RSF604916S, RSF604917S, RSF604918S, RSF604919S, RSF604920S, RSF604921S, RSF604922S, RSF604923S, RSF604924S, RSF604925S, RSF604926S, RSF604927S, RSF604928S, RSF604929S, RSF604931S, RSF604932S, RSF604934S, RSF604935S, RSF604936S, RSF604937S, RSF604938S, RSF604939S, RSF604943S, RSF604945S, RSF604946S, RSF604948S, RSF604949S, RSF604950S, RSF604953S, RSF604955S, RSF604957S, RSF604966S, RSF604969S, RSF604975S, RSF604981S, RSF604983S, RSF604984S, RSF604985S, RSF604991S, RSF604992S, RSF604994S. b. Model Numbers: DDPB3D1: GTIN 00763000178376, Serial Numbers: RSN600151S, RSN600345S, RSN600582S, RSN600650S, RSN600668S, RSN600669S, RSN600670S, RSN600672S, RSN600694S, RSN600699S, RSN600851S, RSN600858S, RSN600861S, RSN600876S, RSN600880S, RSN600922S, RSN600961S, RSN600963S, RSN601156S, RSN601478S, RSN601693S, RSN601804S, RSN601808S, RSN601810S, RSN601830S, RSN601867S, RSN601992S, RSN601993S, RSN602032S, RSN602068S, RSN602136S, RSN602139S, RSN602140S, RSN602142S, RSN602145S, RSN602153S, RSN602155S, RSN602156S, RSN602181S, RSN602185S, RSN602186S, RSN602191S, RSN602196S, RSN602208S, RSN602209S, RSN602219S, RSN602222S, RSN602224S, RSN602226S, RSN602228S, RSN602229S, RSN602230S, RSN602234S, RSN602235S, RSN602236S, RSN602237S, RSN602239S, RSN602247S, RSN602254S, RSN602261S, RSN602265S, RSN602284S, RSN602286S, RSN602287S, RSN602289S, RSN602291S, RSN602292S, RSN602298S, RSN602302S, RSN602304S, RSN602311S, RSN602313S, RSN602316S, RSN602317S, RSN602318S, RSN602319S, RSN602320S, RSN602327S, RSN602333S, RSN602336S, RSN602338S, RSN602344S, RSN602350S, RSN602366S, RSN602371S, RSN602376S, RSN602377S, RSN602380S, RSN602381S, RSN602383S, RSN602385S, RSN602388S, RSN602392S, RSN602394S, RSN602400S, RSN602403S, RSN602407S, RSN602408S, RSN602410S, RSN602411S, RSN602413S, RSN602417S, RSN602420S, RSN602424S, RSN602427S, RSN602431S, RSN602432S, RSN602436S, RSN602437S, RSN602440S, RSN602441S, RSN602443S, RSN602446S, RSN602449S, RSN602450S, RSN602451S, RSN602452S, RSN602458S, RSN602459S, RSN602461S, RSN602475S, RSN602478S, RSN602481S, RSN602482S, RSN602487S, RSN602492S, RSN602493S, RSN602494S, RSN602499S, RSN602502S, RSN602503S, RSN602507S, RSN602508S, RSN602513S, RSN602514S, RSN602516S, RSN602524S, RSN602525S, RSN602526S, RSN602530S, RSN602531S, RSN602548S, RSN602557S, RSN602561S, RSN602562S, RSN602564S, RSN602584S; GTIN 00763000178383, Serial Numbers: RSN600014S, RSN600015S, RSN600016S, RSN600019S, RSN600021S, RSN600022S, RSN600023S, RSN600067S, RSN600073S, RSN600078S, RSN600080S, RSN600081S, RSN600082S, RSN600084S, RSN600085S, RSN600086S, RSN600087S, RSN600088S, RSN600089S, RSN600097S, RSN600101S, RSN600227S, RSN600228S, RSN600229S, RSN600232S, RSN600242S, RSN600245S, RSN600254S, RSN600256S, RSN600259S, RSN600260S, RSN600261S, RSN600263S, RSN600271S, RSN600275S, RSN600285S, RSN600286S, RSN600287S, RSN600288S, RSN600289S, RSN600311S, RSN600323S, RSN600326S, RSN600562S, RSN601010S, RSN601127S, RSN601178S, RSN601222S, RSN601331S, RSN601344S, RSN601370S, RSN601406S, RSN601410S, RSN601696S, RSN601697S, RSN601712S, RSN601713S, RSN601714S, RSN601726S, RSN601728S, RSN601729S, RSN601731S, RSN601735S, RSN601737S, RSN601738S, RSN601742S, RSN601743S, RSN601744S, RSN601745S, RSN601746S, RSN601751S, RSN601756S, RSN601757S, RSN601765S, RSN601768S, RSN601774S, RSN601775S, RSN601778S, RSN601779S, RSN601780S, RSN601781S, RSN601782S, RSN601784S, RSN601785S, RSN601788S, RSN601789S, RSN601792S, RSN601793S, RSN601803S, RSN601805S, RSN601809S, RSN601814S, RSN601815S, RSN601824S, RSN601826S, RSN601836S, RSN601838S, RSN601840S, RSN601844S, RSN601849S, RSN601853S, RSN601857S, RSN601858S, RSN601859S, RSN601863S, RSN601865S, RSN601866S, RSN602074S, RSN602075S, RSN602078S, RSN602080S, RSN602081S, RSN602082S, RSN602084S, RSN602085S, RSN602088S, RSN602090S, RSN602091S, RSN602095S, RSN602096S, RSN602097S, RSN602098S, RSN602099S, RSN602100S, RSN602103S, RSN602104S, RSN602105S, RSN602108S, RSN602109S, RSN602110S, RSN602112S, RSN602113S, RSN602322S, RSN602457S, RSN602460S, RSN602491S, RSN602521S, RSN602563S; DDPB3D4: GTIN 00763000178390, Serial Numbers: RSO600071S, RSO600171S, RSO600224S, RSO600701S, RSO601078S, RSO601186S, RSO601351S, RSO601382S, RSO601825S, RSO602370S, RSO602418S, RSO602598S, RSO602645S, RSO602836S, RSO603379S, RSO603655S, RSO604461S, RSO604504S, RSO604506S, RSO604717S, RSO604787S, RSO604909S, RSO604912S, RSO604913S, RSO604914S, RSO604915S, RSO604916S, RSO604917S, RSO604918S, RSO604919S, RSO604921S, RSO604922S, RSO604923S, RSO604924S, RSO604928S, RSO604929S, RSO604930S, RSO604934S, RSO604935S, RSO604936S, RSO604938S, RSO604941S, RSO604942S, RSO604944S, RSO604948S, RSO604955S, RSO604957S, RSO604960S, RSO604961S, RSO605123S, RSO605606S, RSO605635S, RSO605850S, RSO605900S, RSO606177S, RSO606188S, RSO606294S, RSO606493S, RSO606747S, RSO606931S, RSO606954S, RSO607058S, RSO607115S, RSO607190S, RSO607194S, RSO607201S, RSO607207S, RSO607213S, RSO607219S, RSO607226S, RSO607227S, RSO607262S, RSO607265S, RSO607271S, RSO607287S, RSO607288S, RSO607294S, RSO607301S, RSO607306S, RSO607309S, RSO607315S, RSO607317S, RSO607318S, RSO607324S, RSO607326S, RSO607327S, RSO607329S, RSO607330S, RSO607351S, RSO607441S, RSO607442S, RSO607443S, RSO607444S, RSO607446S, RSO607450S, RSO607452S, RSO607453S, RSO607457S, RSO607460S, RSO607472S, RSO607483S, RSO607484S, RSO607496S, RSO607521S, RSO607573S, RSO607645S, RSO607658S, RSO607659S, RSO607671S, RSO607680S, RSO607681S, RSO607757S, RSO607819S, RSO607820S, RSO607833S, RSO607835S, RSO607840S.RSO607848S, RSO607850S, RSO607920S, RSO608040S, RSO608044S, RSO608079S, RSO608083S, RSO608084S, RSO608085S, RSO608086S, RSO608092S, RSO608097S, RSO608100S, RSO608103S, RSO608105S, RSO608106S, RSO608109S, RSO608118S, RSO608119S, RSO608121S, RSO608123S, RSO608126S, RSO608150S, RSO608154S, RSO608163S, RSO608168S, RSO608227S, RSO608275S, RSO608276S, RSO608278S, RSO608297S, RSO608336S, RSO608337S, RSO608338S, RSO608339S, RSO608345S, RSO608346S, RSO608352S, RSO608356S, RSO608362S, RSO608367S, RSO608368S, RSO608369S, RSO608370S, RSO608373S, RSO608375S, RSO608378S, RSO608379S, RSO608381S, RSO608386S, RSO608387S, RSO608388S, RSO608390S, RSO608392S, RSO608395S, RSO608398S, RSO608400S, RSO608403S, RSO608405S, RSO608407S, RSO608408S, RSO608409S, RSO608412S, RSO608423S, RSO608424S, RSO608427S, RSO608437S, RSO608440S, RSO608441S, RSO608443S, RSO608444S, RSO608445S, RSO608446S, RSO608448S, RSO608454S, RSO608455S, RSO608456S, RSO608457S, RSO608458S, RSO608459S, RSO608460S, RSO608501S, RSO608505S, RSO608506S, RSO608507S, RSO608541S, RSO608545S, RSO608546S, RSO608548S, RSO608549S, RSO608550S, RSO608551S; GTIN 00763000178406, Serial Numbers: RSO600006S, RSO600007S, RSO600010S, RSO600011S, RSO600012S, RSO600014S, RSO600015S, RSO600017S, RSO600018S, RSO600020S, RSO600021S, RSO600022S, RSO600023S, RSO600024S, RSO600025S, RSO600026S, RSO600027S, RSO600028S, RSO600029S, RSO600031S, RSO600032S, RSO600033S, RSO600034S, RSO600035S, RSO600036S, RSO600039S, RSO600040S, RSO600041S, RSO600042S, RSO600043S, RSO600045S, RSO600046S, RSO600047S, RSO600048S, RSO600049S, RSO600050S, RSO600051S, RSO600053S, RSO600054S, RSO600055S, RSO600062S, RSO600064S, RSO600067S, RSO600068S, RSO600069S, RSO600070S, RSO600072S, RSO600073S, RSO600074S, RSO600075S, RSO600076S, RSO600175S, RSO600276S, RSO600277S, RSO600278S, RSO600279S, RSO600280S, RSO600281S, RSO600283S, RSO600284S, RSO600285S, RSO600286S, RSO600287S, RSO600288S, RSO600289S, RSO600290S, RSO600293S, RSO600296S, RSO600297S, RSO600302S, RSO600304S, RSO600307S, RSO600308S, RSO600310S, RSO600312S, RSO600314S, RSO600316S, RSO600317S, RSO600319S, RSO600321S, RSO600322S, RSO600324S, RSO600325S, RSO600326S, RSO600327S, RSO600328S, RSO600330S, RSO600331S, RSO600333S, RSO600335S, RSO600339S, RSO600342S, RSO600343S, RSO600344S, RSO600345S, RSO600346S, RSO600347S, RSO600348S, RSO600350S, RSO600351S, RSO600352S, RSO600353S, RSO600354S, RSO600355S, RSO600357S, RSO600362S, RSO600370S, RSO600373S, RSO600374S, RSO600375S, RSO600378S, RSO600380S, RSO600383S, RSO600384S, RSO600386S, RSO600387S, RSO600389S, RSO600396S, RSO600399S, RSO600402S, RSO600405S, RSO600406S, RSO600409S, RSO600411S, RSO600412S, RSO600413S, RSO600414S, RSO600420S, RSO600421S, RSO600425S, RSO600430S, RSO600431S, RSO600432S, RSO600433S, RSO600434S, RSO600443S, RSO600446S, RSO600452S, RSO600456S, RSO600461S, RSO600462S, RSO600464S, RSO600467S, RSO600470S, RSO600474S, RSO600475S, RSO600479S, RSO600483S, RSO600484S, RSO600485S, RSO600491S, RSO600493S, RSO600497S, RSO600498S, RSO600499S, RSO600500S, RSO600502S, RSO600505S, RSO600506S, RSO600507S, RSO600509S, RSO600510S, RSO600511S, RSO600513S, RSO600517S, RSO600519S, RSO600521S, RSO600523S, RSO600525S, RSO600528S, RSO600529S, RSO600532S, RSO600534S, RSO600537S, RSO600539S, RSO600541S, RSO600546S, RSO600551S, RSO600552S, RSO600558S, RSO600559S, RSO600560S, RSO600564S, RSO600568S, RSO600570S, RSO600571S, RSO600574S, RSO600575S, RSO600576S, RSO600577S, RSO600579S, RSO600580S, RSO600581S, RSO600582S, RSO600583S, RSO601555S, RSO602306S, RSO602307S, RSO602312S, RSO602320S, RSO602322S, RSO602327S, RSO602335S, RSO602337S, RSO602338S, RSO602343S, RSO602345S, RSO602349S, RSO602351S, RSO602352S, RSO602353S, RSO602356S, RSO602359S, RSO602360S, RSO602363S, RSO602366S, RSO602368S, RSO602372S, RSO602379S, RSO602380S, RSO602381S, RSO602382S, RSO602383S, RSO602384S, RSO602385S, RSO602386S, RSO602387S, RSO602388S, RSO602390S, RSO602391S, RSO602392S, RSO602393S, RSO602396S, RSO602399S, RSO602400S, RSO602401S, RSO602402S, RSO602403S, RSO602404S, RSO602405S, RSO602406S, RSO602409S, RSO602410S, RSO602411S, RSO602412S, RSO602414S, RSO602415S, RSO602416S, RSO602419S, RSO602420S, RSO602421S, RSO602422S, RSO602423S, RSO602424S, RSO602426S, RSO602427S, RSO602428S, RSO602429S, RSO602430S, RSO602431S, RSO602433S, RSO602434S, RSO602436S, RSO602437S, RSO602438S, RSO602439S, RSO602441S, RSO602442S, RSO602443S, RSO602444S, RSO602445S, RSO602446S, RSO602447S, RSO602448S, RSO602453S, RSO602455S, RSO602456S, RSO602457S, RSO602458S, RSO602459S, RSO602460S, RSO602461S, RSO602462S, RSO602463S, RSO602464S, RSO602465S, RSO602466S, RSO602467S, RSO602468S, RSO602469S, RSO602470S, RSO602471S, RSO602472S, RSO602473S, RSO602474S, RSO602475S, RSO602476S, RSO602477S, RSO602486S, RSO602487S, RSO602497S, RSO602499S, RSO602502S, RSO602504S, RSO602508S, RSO602511S, RSO602512S, RSO602513S, RSO602515S, RSO602523S, RSO602540S, RSO602594S, RSO602620S, RSO602622S, RSO602623S, RSO602626S, RSO602633S, RSO602648S, RSO602652S, RSO602654S, RSO602656S, RSO602657S, RSO602658S, RSO602659S, RSO602661S, RSO602662S, RSO602664S, RSO602665S, RSO602667S, RSO602668S, RSO602669S, RSO602670S, RSO602671S, RSO602672S, RSO602673S, RSO602674S, RSO602675S, RSO602676S, RSO602677S, RSO602678S, RSO602679S, RSO602680S, RSO602681S, RSO602682S, RSO602683S, RSO602685S, RSO602686S, RSO602687S, RSO602688S, RSO602689S, RSO602690S, RSO602691S, RSO602692S, RSO602693S, RSO602694S, RSO602695S, RSO602696S, RSO602697S, RSO602698S, RSO602699S, RSO602704S, RSO602706S, RSO602708S, RSO602709S, RSO602712S, RSO602713S, RSO602714S, RSO602715S, RSO602716S, RSO602717S, RSO602725S, RSO602726S, RSO602727S, RSO602730S, RSO602749S, RSO602751S, RSO602752S, RSO602761S, RSO602762S, RSO602769S, RSO602772S, RSO602773S, RSO602780S, RSO602792S, RSO604087S, RSO604089S, RSO604090S, RSO604091S, RSO604092S, RSO604094S, RSO604095S, RSO604096S, RSO604097S, RSO604099S, RSO604100S, RSO604101S, RSO604102S, RSO604103S, RSO604104S, RSO604106S, RSO604108S, RSO604110S, RSO604113S, RSO604114S, RSO604119S, RSO604120S, RSO604554S, RSO604572S, RSO604573S, RSO604574S, RSO604576S, RSO604584S, RSO604597S, RSO604604S, RSO604607S, RSO604609S, RSO604631S, RSO604632S, RSO604634S, RSO604635S, RSO604636S, RSO604637S, RSO604639S, RSO604640S, RSO604641S, RSO604642S, RSO604643S, RSO604644S, RSO604645S, RSO604646S, RSO604648S, RSO604650S, RSO604651S, RSO604652S, RSO604655S, RSO604657S, RSO604658S, RSO604660S, RSO604662S, RSO604667S, RSO604672S, RSO604673S, RSO604675S, RSO604676S, RSO604677S, RSO604679S, RSO604683S, RSO604684S, RSO604686S, RSO604688S, RSO604689S, RSO604690S, RSO604691S, RSO604693S, RSO604695S, RSO604696S, RSO604701S, RSO604702S, RSO604704S, RSO604706S, RSO604707S, RSO604709S, RSO604711S, RSO604712S, RSO604715S, RSO604719S, RSO604720S, RSO604721S, RSO604722S, RSO604723S, RSO604724S, RSO604725S, RSO604727S, RSO604731S, RSO604732S, RSO604733S, RSO604736S, RSO604741S, RSO604742S, RSO604745S, RSO604746S, RSO604748S, RSO604750S, RSO604752S, RSO604753S, RSO604758S, RSO604759S, RSO604762S, RSO604763S, RSO604765S, RSO604768S, RSO604770S, RSO604771S, RSO604772S, RSO604778S, RSO604780S, RSO604781S, RSO604782S, RSO604789S, RSO604790S, RSO604792S, RSO604795S, RSO604796S, RSO604798S, RSO604801S, RSO604804S, RSO604806S, RSO604808S, RSO604809S, RSO604811S, RSO604812S, RSO604816S, RSO604817S, RSO604818S, RSO604819S, RSO604822S, RSO604823S, RSO604824S, RSO604826S, RSO604828S, RSO604830S, RSO604831S, RSO604832S, RSO604833S, RSO604834S, RSO604835S, RSO604836S, RSO604837S, RSO604840S, RSO604841S, RSO604842S, RSO604843S, RSO604844S, RSO604845S, RSO604848S, RSO604850S, RSO604851S, RSO604852S, RSO604853S, RSO604854S, RSO604855S, RSO604857S, RSO604859S, RSO604861S, RSO604862S, RSO604863S, RSO604864S, RSO604865S, RSO604866S, RSO604868S, RSO604871S, RSO604873S, RSO604875S, RSO604877S, RSO604878S, RSO604879S, RSO604882S, RSO604883S, RSO604884S, RSO604885S, RSO604886S, RSO604888S, RSO604889S, RSO604891S, RSO604892S, RSO604896S, RSO604898S, RSO604899S, RSO605546S, RSO605778S, RSO605920S, RSO605921S, RSO605962S, RSO606002S, RSO606003S, RSO606017S, RSO606019S, RSO606028S, RSO606030S, RSO606032S, RSO606040S, RSO606042S, RSO606052S, RSO606053S, RSO606066S, RSO606068S, RSO606070S, RSO606073S, RSO606077S, RSO606079S, RSO606082S, RSO606083S, RSO606086S, RSO606087S, RSO606091S, RSO606093S, RSO606098S, RSO606102S, RSO606108S, RSO606109S, RSO606112S, RSO606115S, RSO606117S, RSO606119S, RSO606129S, RSO606137S, RSO606138S, RSO606139S, RSO606141S, RSO606142S, RSO606149S, RSO606151S, RSO606156S, RSO606162S, RSO606164S, RSO606169S, RSO606172S, RSO606175S, RSO606176S, RSO606181S, RSO606196S, RSO606198S, RSO606199S, RSO606200S, RSO606202S, RSO606204S, RSO606205S, RSO606206S, RSO606207S, RSO606208S, RSO606210S, RSO606263S, RSO606315S, RSO606350S, RSO606358S, RSO606363S, RSO606387S, RSO606397S, RSO606399S, RSO606403S, RSO606412S, RSO606415S, RSO606446S, RSO606449S, RSO606453S, RSO606454S, RSO606458S, RSO606468S, RSO606471S, RSO606472S, RSO606479S, RSO606586S, RSO606636S, RSO606638S, RSO606643S, RSO606664S, RSO606665S, RSO606668S, RSO606671S, RSO606672S, RSO606674S, RSO606675S, RSO606676S, RSO606678S, RSO606679S, RSO606683S, RSO606684S, RSO606690S, RSO606692S, RSO606694S, RSO606695S, RSO606696S, RSO606699S, RSO606701S, RSO606703S, RSO606705S, RSO606707S, RSO606710S, RSO606712S, RSO606713S, RSO606714S, RSO606715S, RSO606716S, RSO606717S, RSO606718S, RSO606719S, RSO606720S, RSO606721S, RSO606722S, RSO606723S, RSO606725S, RSO606726S, RSO606727S, RSO606728S, RSO606729S, RSO606730S, RSO606731S, RSO606733S, RSO606736S, RSO606737S, RSO606738S, RSO606740S, RSO606743S, RSO606744S, RSO606745S, RSO606748S, RSO606752S, RSO606753S, RSO606755S, RSO606757S, RSO606760S, RSO606761S, RSO606762S, RSO606763S, RSO606769S, RSO606771S, RSO606773S, RSO606783S, RSO606784S, RSO606808S, RSO606809S, RSO606810S, RSO606811S, RSO606812S, RSO606813S, RSO606815S, RSO606816S, RSO606817S, RSO606818S, RSO606821S, RSO606822S, RSO606823S, RSO606824S, RSO606825S, RSO606827S, RSO606833S, RSO606837S, RSO606840S, RSO606842S, RSO606843S, RSO606844S, RSO606845S, RSO606846S, RSO606848S, RSO606850S, RSO606853S, RSO606854S, RSO606855S, RSO606857S, RSO606858S, RSO606860S, RSO606861S, RSO606862S, RSO606863S, RSO606865S, RSO606869S, RSO606872S, RSO606876S, RSO606878S, RSO606881S, RSO606883S, RSO606884S, RSO606890S, RSO606891S, RSO606892S, RSO606896S, RSO606901S, RSO606903S, RSO606906S, RSO606908S, RSO606909S, RSO606910S, RSO606911S, RSO606912S, RSO606927S, RSO606929S, RSO606934S, RSO606935S, RSO606936S, RSO606937S, RSO606938S, RSO606940S, RSO606942S, RSO606944S, RSO606945S, RSO606946S, RSO606947S, RSO607738S, RSO607754S, RSO607759S, RSO607762S, RSO607778S, RSO607785S, RSO607790S, RSO607802S, RSO607810S, RSO607812S, RSO607814S, RSO607816S, RSO607821S, RSO608470S, RSO608477S, RSO608518S, RSO608519S.
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 763-723-4636
• Manufacturer Reason for Recall: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
• FDA Determined Cause: Device Design
• Action: Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. Consignees are asked to quarantine the subset of unused identified Cobalt and Crome devices for retrieval due to potential manufacturing non-conformance and return the inventory to Medtronic. On approximately 08/10/2022, Medtronic notified Risk Managers of the availability of a SW update and actions specific to update the SW on the SmartSync devices, that will in turn update the patient's implanted device during their next clinic visit. In addition, on this same date, a separate communication dated August 2022 is being sent to all affected Implanting Physicians notifying them that a SW update is available and recommended actions to correct this issue with their patient's implanted device. The second notification to physicians did not request returned confirmation.
• Quantity in Commerce: 2866 units
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.