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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave LiIon Battery Pack

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  Class 1 Device Recall Cardiosave LiIon Battery Pack see related information
Date Initiated by Firm September 21, 2021
Create Date October 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-0091-2022
Recall Event ID 88719
510(K)Number K112372  K151254  K163542  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
Code Information 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  
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Rachana Patel
973-709-7412
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On September 21, 2021, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were alerted that affected battery packs may experience unexpected short battery runtime. Actions to be Taken by Customer: - Examine your inventory to determine if you have any of the affected product - Replace any affected battery with an unaffected battery, and remove affected product from areas of use - Dispose of affected batteries properly in accordance with local statutes and the labeling on the battery pack - Customers with affected product are eligible for credit or replacement at no cost - Forward information to all current and potential Cardiosave Hybrid and Cardiosave Rescue IABP users within your hospital/facility - Distributors should forward notification to affected customers - Respond to firm's notification by completing the included response form If you have any questions, please contact your Datascope/Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00a.m. and 6:00p.m. EST.
Quantity in Commerce 131 (US), 117 (OUS)
Distribution Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates, Philippines, and Russia
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
510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.
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