medical Class I Updated 2021-10-27

Datascope Corp. recalls Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Comp

Recalled Product

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

Hazard / Issue

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Battery Pack Serial Numbers: 192224349IP, 191908720IP, 202369811IP, 202791944IP, 191848115IP, 192099841IP, 192103741IP, 192104141IP, 171218521PE, 181642339PE, 202321308IP, 191912520IP, 191874716IP, 191922620IP, 181642639PE, 192185446IP, 171277935PE, 192190247IP, 202400219IP, 202323808IP, 191910720IP, 181661142PE, 192245250IP, 202599332IP, 181645841PE, 181526530PE, 202403719IP, 181705244PE, 192104541IP, 191787312IP, 181646041PE, 191955422IP, 202389919IP, 191822513IP, 191853415IP, 192004724IP, 192196447IP, 192155645IP, 202330609IP, 171325749PE, 192018828IP, 191778911IP, 192187947IP, 192196247IP, 181609237PE, 192098341IP, 191972823IP, 191860615IP, 202719740IP, 202334109IP, 202651035IP, 191852615IP, 192173146IP, 202386519IP, 202398619IP, 202416720IP, 202599432IP, 191956322IP, 192205847IP, 192220349IP, 192081138IP, 202617233IP, 181659242PE, 202266705IP, 171255732PE, 192179046IP, 192179246IP, 202280605IP, 181673143PE, 192083838IP, 192106442IP, 192216649IP, 191956122IP, 181721730IP, 191943120IP, 191971023IP, 181405120PE, 181474326PE, 181440222PE, 192225649IP, 191969623IP, 192220749IP, 181706344PE, 181694644PE, 191968223IP, 202593632IP, 191863015IP, 171264133PE, 191872616IP, 181487828PE, 171337749PE, 181477426PE, 181748032IP, 191790412IP, 191902319IP, 192195547IP, 192200947IP, 191968723IP, 202552831IP, 191806513IP, 202401419IP, 191904319IP, 181492328PE, 202388319IP, 202482724IP, 192241550IP, 171339849PE, 191831214IP, 192084038IP, 181694244PE, 192210249IP, 202725540IP, 171345550PE, 171348550PE, 191915920IP, 202371511IP, 202723440IP, 202367411IP, 202279305IP, 181513630PE, 181703744PE, 202389819IP, 192175646IP, 192107842IP, 202394719IP, 202401619IP, 192204947IP, 202654636IP, 192196647IP, 192200647IP, 202782744IP. 1. Cardiosave Hybrid. Model Number (UDI Number): 0998-00-0800-31 (10607567109053), 0998-00-0800-32 (10607567111117), 0998-00-0800-33 (10607567109008), 0998-00-0800-35 (10607567109107), 0998-00-0800-36 (10607567114187), 0998-00-0800-45 (10607567108421), 0998-00-0800-52 (10607567108438), 0998-00-0800-53 (10607567108391), 0998-00-0800-55 (10607567108414), 0998-00-0800-65 (10607567113432), 0998-UC-0800-31 (10607567109053), 0998-UC-0800-33 (10607567109008), 0998-UC-0800-52 (10607567108438), 0998-UC-0800-53 (10607567108391), 0998-UC-0800-55 (10607567108414). 2. Cardiosave Rescue. Model Number: 0998-00-0800-83 (10607567108407).
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