• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Crome

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall Crome see related information
Date Initiated by Firm June 22, 2022
Date Posted August 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1490-2022
Recall Event ID 90565
PMA Number P010031S674 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Code Information a. Model Numbers:  DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S;  GTIN 00763000178314, Serial Numbers: RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600232S, RTW600316S, RTW600318S, RTW600321S, RTW600324S, RTW600334S, RTW600335S, RTW600336S, RTW600340S, RTW600341S, RTW600344S, RTW600351S, RTW600356S, RTW600359S, RTW600360S, RTW600361S, RTW600364S, RTW600387S, RTW600388S, RTW600389S, RTW600390S, RTW600391S, RTW600392S, RTW600393S, RTW600394S, RTW600395S, RTW600396S, RTW600397S, RTW600398S, RTW600399S, RTW600400S, RTW600401S, RTW600403S, RTW600404S, RTW600405S, RTW600408S, RTW600410S, RTW600412S, RTW600413S, RTW600415S, RTW600417S, RTW600419S, RTW600420S, RTW600421S, RTW600422S, RTW600425S, RTW600426S, RTW600427S, RTW600428S, RTW600430S, RTW600433S, RTW600436S, RTW600441S, RTW600444S, RTW600445S, RTW600449S, RTW600450S, RTW600452S, RTW600453S, RTW600454S, RTW600456S, RTW600459S, RTW600461S, RTW600463S, RTW600465S, RTW600466S, RTW600467S, RTW600468S, RTW600469S, RTW600470S, RTW600471S, RTW600474S, RTW600476S, RTW600478S, RTW600479S, RTW600481S, RTW600482S, RTW600486S, RTW600487S, RTW600488S, RTW600489S, RTW600490S, RTW600492S, RTW600493S, RTW600494S, RTW600495S, RTW600496S, RTW600497S, RTW600498S, RTW600500S, RTW600501S, RTW600502S, RTW600503S, RTW600505S, RTW600506S, RTW600507S, RTW600508S, RTW600509S, RTW600510S, RTW600511S, RTW600512S, RTW600513S, RTW600514S, RTW600515S, RTW600516S, RTW600517S, RTW600518S, RTW600519S, RTW600520S, RTW600521S, RTW600522S, RTW600523S, RTW600529S, RTW600533S, RTW600534S, RTW600536S, RTW600538S, RTW600541S, RTW600544S, RTW600545S, RTW600546S, RTW600549S, RTW600554S;  DTPC2D1:  GTIN 00763000178307, Serial Numbers: RTX600387S, RTX600584S, RTX600586S, RTX600587S, RTX600597S;  GTIN 00763000178321, Serial Numbers: RTX600014S, RTX600015S, RTX600016S, RTX600018S, RTX600022S, RTX600025S, RTX600027S, RTX600028S, RTX600029S, RTX600030S, RTX600034S, RTX600035S, RTX600088S, RTX600163S, RTX600179S, RTX600202S, RTX600231S, RTX600243S, RTX600247S, RTX600249S, RTX600251S, RTX600252S, RTX600258S, RTX600262S, RTX600268S, RTX600269S, RTX600278S, RTX600286S, RTX600463S, RTX600464S, RTX600466S, RTX600467S, RTX600471S, RTX600472S, RTX600474S, RTX600475S, RTX600476S, RTX600477S, RTX600478S, RTX600482S, RTX600483S, RTX600484S, RTX600485S, RTX600486S, RTX600487S, RTX600490S, RTX600491S, RTX600492S, RTX600493S, RTX600494S, RTX600495S, RTX600500S, RTX600501S, RTX600502S, RTX600503S, RTX600505S, RTX600506S, RTX600507S, RTX600508S, RTX600509S, RTX600510S, RTX600511S, RTX600512S, RTX600513S, RTX600514S, RTX600515S, RTX600516S, RTX600517S, RTX600518S, RTX600521S, RTX600530S, RTX600532S, RTX600533S, RTX600534S, RTX600535S, RTX600536S, RTX600537S, RTX600538S, RTX600539S, RTX600541S, RTX600542S, RTX600543S, RTX600544S, RTX600546S, RTX600547S, RTX600548S, RTX600549S, RTX600550S, RTX600551S, RTX600552S, RTX600554S, RTX600555S, RTX600556S, RTX600557S, RTX600558S, RTX600559S, RTX600560S, RTX600561S, RTX600564S, RTX600566S, RTX600567S, RTX600568S, RTX600569S, RTX600570S, RTX600571S, RTX600572S, RTX600573S, RTX600574S, RTX600575S, RTX600576S, RTX600577S, RTX600578S, RTX600579S, RTX600598S, RTX600600S, RTX600602S, RTX600603S, RTX600604S, RTX600605S, RTX600606S, RTX600607S, RTX600608S, RTX600609S, RTX600610S, RTX600611S, RTX600612S, RTX600613S, RTX600615S, RTX600618S, RTX600619S, RTX600620S, RTX600621S, RTX600622S, RTX600623S, RTX600624S, RTX600625S, RTX600626S, RTX600627S, RTX600628S, RTX600629S, RTX600630S, RTX600631S, RTX600632S;  b. Model Numbers: DTPC2QQ:  GTIN 00763000178253, Serial Numbers: RTS600220S, RTS600260S, RTS600972S;  GTIN 00763000178277, Serial Numbers: RTS600014S, RTS600015S, RTS600016S, RTS600017S, RTS600018S, RTS600020S, RTS600022S, RTS600024S, RTS600026S, RTS600027S, RTS600029S, RTS600030S, RTS600031S, RTS600032S, RTS600034S, RTS600035S, RTS600036S, RTS600037S, RTS600038S, RTS600039S, RTS600041S, RTS600042S, RTS600043S, RTS600044S, RTS600045S, RTS600048S, RTS600050S, RTS600051S, RTS600053S, RTS600055S, RTS600056S, RTS600058S, RTS600060S, RTS600061S, RTS600063S, RTS600064S, RTS600066S, RTS600069S, RTS600228S, RTS600235S, RTS600274S, RTS600275S, RTS600281S, RTS600284S, RTS600286S, RTS600292S, RTS600293S, RTS600295S, RTS600296S, RTS600300S, RTS600301S, RTS600302S, RTS600303S, RTS600304S, RTS600305S, RTS600306S, RTS600308S, RTS600309S, RTS600310S, RTS600311S, RTS600312S, RTS600313S, RTS600315S, RTS600317S, RTS600318S, RTS600319S, RTS600320S, RTS600321S, RTS600323S, RTS600325S, RTS600326S, RTS600327S, RTS600328S, RTS600329S, RTS600330S, RTS600331S, RTS600333S, RTS600335S, RTS600337S, RTS600343S, RTS600344S, RTS600345S, RTS600346S, RTS600348S, RTS600349S, RTS600351S, RTS600352S, RTS600353S, RTS600354S, RTS600355S, RTS600356S, RTS600358S, RTS600359S, RTS600360S, RTS600369S, RTS600373S, RTS600425S, RTS600426S, RTS600441S, RTS600484S, RTS600485S, RTS600486S, RTS600487S, RTS600488S, RTS600489S, RTS600490S, RTS600491S, RTS600492S, RTS600493S, RTS600494S, RTS600495S, RTS600496S, RTS600497S, RTS600498S, RTS600510S, RTS600511S, RTS600512S, RTS600513S, RTS600514S, RTS600515S, RTS600516S, RTS600517S, RTS600518S, RTS600519S, RTS600520S, RTS600521S, RTS600522S, RTS600524S, RTS600525S, RTS600526S, RTS600527S, RTS600528S, RTS600529S, RTS600530S, RTS600531S, RTS600532S, RTS600533S, RTS600534S, RTS600535S, RTS600536S, RTS600538S, RTS600539S, RTS600540S, RTS600541S, RTS600542S, RTS600543S, RTS600554S, RTS600555S, RTS600556S, RTS600557S, RTS600558S, RTS600559S, RTS600560S, RTS600561S, RTS600562S, RTS600563S, RTS600564S, RTS600565S, RTS600566S, RTS600567S, RTS600568S, RTS600569S, RTS600570S, RTS600571S, RTS600572S, RTS600573S, RTS600574S, RTS600575S, RTS600576S, RTS600577S, RTS600578S, RTS600579S, RTS600580S, RTS600581S, RTS600582S, RTS600583S, RTS600584S, RTS600585S, RTS600586S, RTS600587S, RTS600588S, RTS600590S, RTS600592S, RTS600596S, RTS600597S, RTS600600S, RTS600605S, RTS600606S, RTS600607S, RTS600610S, RTS600611S, RTS600616S, RTS600629S, RTS600637S, RTS600638S, RTS600639S, RTS600643S, RTS600648S, RTS600650S, RTS600651S, RTS600656S, RTS600661S, RTS600663S, RTS600665S, RTS600667S, RTS600671S, RTS600673S, RTS600675S, RTS600676S, RTS600677S, RTS600679S, RTS600687S, RTS600693S, RTS600697S, RTS600698S, RTS600700S, RTS600705S, RTS600706S, RTS600719S, RTS600720S, RTS600833S, RTS600842S, RTS600846S, RTS600849S, RTS600852S, RTS600857S, RTS600866S, RTS600874S, RTS600880S, RTS600883S, RTS600884S, RTS600885S, RTS600886S, RTS600888S, RTS600889S, RTS600897S, RTS600900S, RTS600901S, RTS600908S, RTS600910S, RTS600911S, RTS600912S, RTS600913S, RTS600914S, RTS600915S, RTS600916S, RTS600917S, RTS600918S, RTS600919S, RTS600920S, RTS600921S, RTS600922S, RTS600923S, RTS600924S, RTS600925S, RTS600926S, RTS600927S, RTS600928S, RTS600929S, RTS600930S, RTS600931S, RTS600932S, RTS600933S, RTS600934S, RTS600936S, RTS600937S, RTS600938S, RTS600939S, RTS600940S, RTS600941S, RTS600943S, RTS600944S, RTS600945S, RTS600947S, RTS600948S, RTS600949S, RTS600957S, RTS600959S, RTS600967S, RTS600991S, RTS600993S, RTS600995S, RTS600997S, RTS600998S, RTS600999S, RTS601000S, RTS601001S, RTS601002S, RTS601003S, RTS601007S, RTS601008S, RTS601009S, RTS601012S, RTS601017S, RTS601019S, RTS601020S, RTS601021S, RTS601022S, RTS601024S, RTS601029S, RTS601034S, RTS601036S, RTS601038S, RTS601039S, RTS601040S, RTS601041S, RTS601042S, RTS601043S, RTS601044S, RTS601045S, RTS601047S, RTS601048S, RTS601049S, RTS601050S, RTS601051S, RTS601052S, RTS601053S, RTS601054S, RTS601055S, RTS601056S, RTS601057S, RTS601058S, RTS601059S, RTS601060S, RTS601061S, RTS601062S, RTS601063S, RTS601064S, RTS601065S, RTS601066S, RTS601067S, RTS601070S, RTS601071S, RTS601082S, RTS601086S, RTS601087S, RTS601091S, RTS601098S, RTS601100S, RTS601101S, RTS601103S, RTS601105S, RTS601107S, RTS601110S, RTS601111S, RTS601112S, RTS601115S, RTS601116S, RTS601117S, RTS601118S, RTS601119S, RTS601120S, RTS601121S, RTS601122S, RTS601123S, RTS601124S, RTS601125S, RTS601126S, RTS601127S, RTS601128S, RTS601129S, RTS601130S, RTS601131S, RTS601132S, RTS601133S, RTS601134S, RTS601135S, RTS601136S, RTS601137S, RTS601138S, RTS601139S, RTS601140S, RTS601141S, RTS601142S, RTS601143S, RTS601144S, RTS601145S, RTS601146S, RTS601147S, RTS601148S, RTS601149S, RTS601150S, RTS601151S, RTS601152S, RTS601155S, RTS601158S, RTS601159S, RTS601160S, RTS601161S, RTS601163S, RTS601164S, RTS601165S, RTS601166S, RTS601167S, RTS601168S, RTS601169S, RTS601170S, RTS601171S, RTS601172S, RTS601173S, RTS601174S, RTS601175S, RTS601176S, RTS601177S, RTS601178S, RTS601179S, RTS601180S, RTS601181S, RTS601182S, RTS601183S, RTS601184S, RTS601185S, RTS601186S, RTS601187S, RTS601188S, RTS601189S, RTS601190S, RTS601191S, RTS601192S, RTS601193S, RTS601194S, RTS601195S, RTS601198S, RTS601199S, RTS601200S, RTS601201S, RTS601202S, RTS601203S, RTS601204S, RTS601205S, RTS601206S, RTS601207S, RTS601208S, RTS601209S, RTS601210S, RTS601211S, RTS601212S, RTS601215S, RTS601216S, RTS601217S, RTS601218S, RTS601219S, RTS601220S, RTS601221S, RTS601223S, RTS601224S, RTS601225S, RTS601226S, RTS601227S, RTS601228S, RTS601229S, RTS601230S, RTS601231S, RTS601232S, RTS601233S, RTS601234S, RTS601235S, RTS601236S, RTS601237S, RTS601238S, RTS601240S, RTS601242S;  DTPC2Q1:  GTIN 00763000178260, Serial Numbers: RTT600423S, RTT600424S, RTT600434S;  GTIN 00763000178284, Serial Numbers: RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600023S, RTT600133S, RTT600135S, RTT600142S, RTT600148S, RTT600196S, RTT600204S, RTT600215S, RTT600304S, RTT600305S, RTT600307S, RTT600308S, RTT600309S, RTT600314S, RTT600315S, RTT600316S, RTT600318S, RTT600319S, RTT600323S, RTT600326S, RTT600327S, RTT600329S, RTT600330S, RTT600331S, RTT600334S, RTT600335S, RTT600337S, RTT600338S, RTT600341S, RTT600342S, RTT600343S, RTT600344S, RTT600345S, RTT600346S, RTT600347S, RTT600348S, RTT600350S, RTT600351S, RTT600353S, RTT600354S, RTT600355S, RTT600357S, RTT600358S, RTT600359S, RTT600360S, RTT600361S, RTT600363S, RTT600365S, RTT600368S, RTT600369S, RTT600370S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600375S, RTT600376S, RTT600377S, RTT600378S, RTT600380S, RTT600382S, RTT600383S, RTT600386S, RTT600387S, RTT600388S, RTT600389S, RTT600391S, RTT600392S, RTT600393S, RTT600394S, RTT600396S, RTT600397S, RTT600398S, RTT600399S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600406S, RTT600407S, RTT600408S, RTT600409S, RTT600410S, RTT600411S, RTT600412S, RTT600413S, RTT600414S, RTT600415S, RTT600416S, RTT600417S, RTT600418S, RTT600419S, RTT600428S, RTT600442S, RTT600443S, RTT600444S, RTT600445S, RTT600446S, RTT600447S, RTT600448S, RTT600449S, RTT600451S, RTT600452S, RTT600454S, RTT600455S.  
Recalling Firm/
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
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 2
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 866 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.
PMA Database PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.