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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Disk

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  Class 2 Device Recall Safety Disk see related information
Date Initiated by Firm February 28, 2023
Date Posted March 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1278-2023
Recall Event ID 91652
510(K)Number K112372  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Code Information Serial Numbers: DR349559C2 DR352554E2 DR354264F2 DR350872D2 DR351891D2 DR349620C2 DR354572F2 DR353203E2 DR354251F2 DR352588E2 DR352572E2 DR350988D2 DR347950B2 DR348991C2 DR351959D2 DR348566B2 DR353163E2 DR351013D2 DR349563C2 DR352526E2 DR351919D2 DR352548E2 DR351927D2 DR344801L1 DR352926E2 DR353698F2 DR352211D2 DR350876D2 DR354556F2 DR350998D2 DR353686F2 DR347941B2 DR354568F2 DR354254F2 DR348987C2 DR353693F2 DR351004D2 DR351330D2 DR348525B2 DR352593E2 DR348530B2 DR351923D2 DR352571E2 DR351907D2 DR351331D2 DR350854D2 DR352589E2 DR347949B2 DR354551F2 DR351872D2 DR350997D2 DR348999C2 DR352537E2 DR351017D2 DR352585E2 DR351403D2 DR350878D2 DR349527C2 DR349558C2 DR352573E2 DR347945B2 DR354244F2 DR352167D2 DR351323D2 DR352199D2 DR352557E2 DR354583F2 DR350863D2 DR348552B2 DR348561B2 DR351376D2 DR353162E2 DR351894D2 DR352192D2 DR354232F2 DR347936B2 DR350994D2 DR345595L1 DR348982C2 DR350867D2 DR351374D2 DR350849D2 DR345642L1 DR354557F2 DR351036D2 DR352591E2 DR353681F2 DR351031D2 DR349568C2 DR352172D2 DR354550F2 DR351358D2 DR354854F2 DR351356D2 DR347959B2 DR348534B2 DR354573F2 DR350873D2 DR352549E2 DR353206E2 DR351320D2 DR351011D2 DR354245F2 DR351368D2 DR353184E2 DR350893D2 DR351379D2 DR351399D2 DR348984C2 DR353190E2 DR351367D2 DR351911D2 DR352565E2 DR348958C2 DR350973D2 DR352567E2 DR349621C2 DR351880D2 DR354243F2 DR348974C2 DR348533B2 DR348988C2 DR348963C2 DR348554B2 DR349590C2 DR353148E2 DR351961D2 DR346935A2 DR352190D2 DR350870D2 DR353177E2 DR352164D2 DR352576E2 DR349578C2 DR348522B2 DR352189D2 DR354257F2 DR345342L1 DR350874D2 DR349575C2 DR348526B2 DR347938B2 DR351395D2 DR353158E2 DR351899D2 DR350869D2 DR354837F2 DR354270F2 DR349515C2 DR354537F2 DR351369D2 DR352529E2 DR350862D2 DR348558B2 DR352181D2 DR351965D2 DR348995C2 DR352566E2 DR353663F2 DR354849F2 DR348540B2 DR350880D2 DR354247F2 DR351409D2 DR350987D2 DR354819F2 DR351377D2 DR351021D2 DR349525C2 DR352168D2 DR350883D2 DR349540C2 DR349617C2 DR349622C2 DR351888D2 DR349544C2 DR352552E2 DR351402D2 DR352580E2 DR349512C2 DR352202D2 DR353664F2 DR351936D2 DR348986C2 DR354566F2 DR351890D2 DR353181E2 DR350991D2 DR351002D2 DR347940B2 DR351916D2 DR351023D2 DR352531E2 DR348560B2 DR350852D2 DR354538F2 DR350865D2 DR349523C2 DR349580C2 DR353192E2 DR350977D2 DR351020D2 DR351334D2 DR352551E2 DR352179D2 DR351892D2 DR353179E2 DR350889D2 DR352185D2 DR350967D2 DR348539B2 DR351007D2 DR349613C2 DR351877D2 DR353678F2 DR350877D2 DR352570E2 DR349592C2 DR353193E2 DR349605C2 DR350894D2 DR354249F2 DR351913D2 DR351914D2 DR351407D2 DR353161E2 DR348555B2 DR347960B2 DR351953D2 DR351372D2 DR353689F2 DR349543C2 DR348964C2 DR349588C2 DR354542F2 DR351326D2 DR349566C2 DR351876D2 DR354842F2 DR351337D2 DR350971D2 DR347953B2 DR351008D2 DR349607C2 DR349601C2 DR353142E2 DR351900D2 DR348567B2 DR352536E2 DR350890D2 DR350892D2 DR348528B2 DR354851F2 DR352196D2 DR351917D2 DR351035D2 DR354269F2 DR353696F2 DR349625C2 DR351349D2 DR348537B2 DR351952D2 DR351942D2 DR351001D2 DR351345D2 DR349560C2 DR348564B2 DR353146E2 DR345634L1 DR348531B2 DR350992D2 DR346939A2 DR353702F2 DR352577E2 DR347958B2 DR352194D2 DR352203D2 DR351874D2 DR347968B2 DR354545F2 DR352555E2 DR353182E2 DR351370D2 DR352201D2 DR351918D2 DR354234F2 DR348957C2 DR354579F2 DR351005D2 DR349593C2 DR351930D2 DR349612C2 DR351014D2 DR349618C2 DR351037D2 DR354260F2 DR354561F2 DR351351D2 DR350972D2 DR352583E2 DR352178D2 DR352558E2 DR351335D2 DR347931B2 DR351032D2 DR352207D2 DR351029D2 DR351346D2 DR352175D2 DR352198D2 DR350982D2 DR348989C2 DR349556C2 DR353680F2 DR349608C2 DR352595E2 DR349626C2 DR351352D2 DR353171E2 DR352208D2 DR349557C2 DR351386D2 DR351360D2 DR354845F2 DR351015D2 DR348962C2 DR347937B2 DR350976D2 DR349589C2 DR351884D2 DR352534E2 DR351383D2 DR352592E2 DR349509C2 DR350884D2 DR351381D2 DR353675F2 DR351388D2 DR349000C2 DR351912D2 DR350996D2 DR354843F2 DR345347L1 DR354236F2 DR353687F2 DR350968D2 DR348998C2 DR354263F2 DR351878D2 DR351898D2 DR351003D2 DR353665F2 DR350861D2 DR347961B2 DR352596E2 DR349603C2 DR351398D2 DR351905D2 DR348529B2 DR351408D2 DR351033D2 DR353691F2 DR350866D2 DR353178E2 DR349602C2 DR351935D2 DR353666F2 DR347955B2 DR354512F2 DR348551B2 DR354541F2 DR354575F2 DR351401D2 DR351910D2 DR345664L1 DR351022D2 DR354235F2 DR354547F2 DR351885D2 DR351378D2 DR350895D2 DR351355D2 DR353174E2 DR344911L1 DR351365D2 DR349522C2 DR349581C2 DR352180D2 DR351371D2 DR353661F2 DR351384D2 DR352200D2 DR352560E2 DR353141E2 DR354237F2 DR352587E2 DR346917A2 DR351902D2 DR348523B2 DR351870D2 DR353692F2 DR354546F2 DR350975D2 DR350985D2 DR351385D2 DR351883D2 DR353187E2 DR354839F2 DR352590E2 DR351018D2 DR350881D2 DR352540E2 DR354829F2 DR350853D2 DR354822F2 DR352553E2 DR345622L1 DR351012D2 DR350855D2 DR349600C2 DR353699F2 DR350983D2 DR353201E2 DR349553C2 DR348546B2 DR350984D2 DR351387D2 DR354277F2 DR349572C2 DR351406D2 DR350864D2 DR351929D2 DR354233F2 DR352533E2 DR352191D2 DR348553B2 DR353149E2 DR354577F2 DR348971C2 DR349534C2 DR351944D2 DR347966B2 DR351939D2 DR347935B2 DR351026D2 DR354240F2 DR351875D2 DR353172E2 DR351958D2 DR354570F2 DR351949D2 DR351009D2 DR353673F2 DR348994C2 DR352530E2 DR345344L1 DR351340D2 DR353195E2 DR349542C2 DR345638L1 DR350859D2 DR352579E2 DR348569B2 DR349567C2 DR351024D2 DR346928A2 DR350875D2 DR350857D2 DR353175E2 DR348997C2 DR353204E2 DR349561C2 DR350966D2 DR353697F2 DR352556E2 DR351893D2 DR348959C2 DR348556B2 DR351016D2 DR353667F2 DR345643L1 DR354852F2 DR354835F2 DR352582E2 DR349002C2 DR351886D2 DR351950D2 DR352183D2 DR351951D2 DR352581E2 DR351895D2 DR351363D2 DR349610C2 DR351375D2 DR350999D2 DR345335L1 DR353166E2 DR354855F2 DR351901D2 DR350981D2 DR352584E2 DR347964B2 DR348961C2 DR347969B2 DR351010D2 DR351364D2 DR347963B2 DR346918A2 DR345635L1 DR351896D2 DR353669F2 DR350879D2 DR354581F2 DR353170E2 DR350871D2 DR348980C2 DR349564C2 DR349606C2 DR354840F2 DR353682F2 DR351348D2 DR351941D2 DR351394D2 DR344917L1 DR348542B2 DR352171D2 DR346925A2 DR349609C2 DR351025D2 DR348535B2 DR353183E2 DR351034D2 DR354576F2 DR351879D2 DR354544F2 DR350848D2 DR347934B2 DR354255F2 DR349591C2 DR353684F2 DR354543F2 DR351887D2 DR350891D2 DR350980D2 DR345334L1 DR351382D2 DR351028D2 DR352538E2 DR351897D2 DR351380D2 DR350858D2 DR347932B2 DR348996C2 DR352569E2 DR349584C2 DR349585C2 DR353194E2 DR348968C2 DR349573C2 DR351932D2 DR353704F2 DR352578E2 DR352527E2 DR354847F2 DR354565F2 DR350978D2 DR349555C2 DR352914E2 DR351915D2 DR349541C2 DR352188D2 DR351027D2 DR351366D2 DR351404D2 DR350856D2 DR351316D2 DR347956B2 DR351332D2 DR350974D2 DR352166D2 DR351906D2 DR354258F2 DR345330L1 DR354239F2 DR353668F2 DR352574E2 DR349611C2 DR351343D2 DR352210D2 DR348527B2 DR351396D2 DR350969D2 DR353189E2 DR351347D2 DR346936A2 DR353154E2 DR352913E2 DR351000D2 DR351319D2 DR348548B2 DR353205E2 DR354567F2 DR351019D2 DR353153E2 DR347952B2 DR354826F2 DR352173D2 DR349562C2 DR353690F2 DR351947D2 DR353695F2 DR354246F2 DR351315D2 DR352920E2 DR349570C2 DR354539F2 DR351318D2 DR354564F2 DR351928D2 DR352532E2 DR348993C2 DR350993D2 DR346934A2 DR344921L1 DR351405D2 DR350850D2 DR350885D2 DR351333D2 DR352568E2 DR352206D2 DR351329D2 DR350989D2 DR351904D2 DR353191E2 DR351871D2 DR352550E2 DR350851D2 DR354856F2 DR351006D2 DR345338L1 DR351873D2 DR347939B2 DR347965B2 DR353180E2 DR350970D2 DR350860D2 DR347962B2 DR351933D2 DR352546E2 DR351373D2 DR352205D2 DR350995D2 DR349594C2 DR351397D2 DR347942B2 DR351361D2 DR351931D2 DR352543E2 DR349577C2 DR354242F2 DR352586E2 DR354574F2 DR354824F2 DR347943B2 DR354250F2 DR351354D2 DR351948D2 DR350979D2 DR347951B2
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Marylou Insinga
973-709-7442
Manufacturer Reason
for Recall		 There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
FDA Determined
Cause 2		 Under Investigation by firm
Action An URGENT MEDICAL DEVICE CORRECTION dated 2/28/23 was sent to customers. User Actions to be taken: A review of our records indicate that you may have a Cardiosave IABP at your facility with an affected Safety Disk or affected spare Safety Disks or PIM assembly installed recently into Cardiosave IABP. 1. Please examine your inventory immediately to determine if you have any Cardiosave IABPs with the affected Safety Disks and/or PIM, or any affected Safety Disk and/or PIM assembly spare parts, per attachment 1. 2. You may continue to use any affected IABPs until replacement parts are installed. Please keep in mind the potential health risks cited above, particularly with prolonged heart rates above 100 beats per minute for three consecutive hours. When transporting patients outside the hospital environment, consider using an unaffected console if available. 3. Should you have any unused affected spare parts of the Safety Disk or PIM Assembly in your inventory, please remove them from areas of use and contact your local Datascope/Getinge Customer Service department at 888-9GETUSA (888 943-8872) to request a return authorization (RMA) and shipping instruction to return the affected product for credit. 4. If you installed an affected spare part into one of your IABPs the Safety Disk will need to be replaced. 5. If you purchased spare parts and they are no longer in your inventory and you are unsure of their location, please contact Getinge Service. Getinge Service will schedule an on-site visit to inspect your IABP/(s) at no cost to your facility. 6. Should you have any affected Cardiosave IABPs you will be contacted by a Getinge Service Representative to schedule an on-site visit to replace the Safety Disk, free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone
Quantity in Commerce 669 safety disks
Distribution Distribution list not yet provided.
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.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
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