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Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097.… recallZ-0091-2022 · Datascope Corp. · initiated Sep 21, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0091-2022
Status
Open, Classified
Initiated by the company
Sep 21, 2021
Posted by the FDA
Oct 20, 2021
Recalling firm
Datascope Corp.
Quantity
131 batteries, 11,517 pumps
Product code
DSP
FDA submissions
K112372, K151254, K163542, K181122
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 description

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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).

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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