Z-0091-2022Class I

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic...

Name: Z-0091-2022 Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic...
Creator: Datascope Corp.
Published: 2021-09-21
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2021-09-21 / Open, Classified / root cause: manufacturing process

FDA source

Datascope Corp. began a recall of 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... on 2021-09-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0091-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-09-21
Posted: 2021-10-20
Recalling firm: Datascope Corp.
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.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: manufacturing process
FDA root cause: 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 On 11/04/2025, Datascope Getinge sent a customer update letter (i.e. Urgent Medical Device Correction) to communicate the IFU Addendum to consignees on 11/04/2025. The addendum communicates changes regarding the battery run time specification. The IFU Addendum updates the battery runtime specification to match those published in the Service Manual in June 2023. The notification also includes information regarding other issues related to the recall and being communicated to users of the Cardiosave pumps.
Quantity in commerce: 131 batteries, 11,517 pumps
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
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-20

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)