Cardiosave Li-Ion Battery Pack — Class I medical device recall Z-0091-2022
Ongoing recall by Datascope Corp., reported 2021-10-27, distributed nationwide. A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirem
| Recall number | Z-0091-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-09-21 |
| Classified | 2021-10-20 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, FR, GB, IE, IN, IT, JP, KR, KW, NL, NO, PH, PK, RU, SA, SE, SG, TH, TN, TW, ZA |
| UPC / GTIN / UDI-DI | 10607567108391, 10607567108407, 10607567108414, 10607567108421, 10607567108438, 10607567109008, 10607567109053, 10607567109107, 10607567111117, 10607567113432, 10607567114187 |
| Serial numbers | 171218521PE, 171255732PE, 171264133PE, 171277935PE, 171325749PE, 171337749PE, 171339849PE, 171345550PE, 171348550PE, 181405120PE, 181440222PE, 181474326PE, 181477426PE, 181487828PE, 181492328PE, 181513630PE, 181526530PE, 181609237PE, 181642339PE, 181642639PE, 181645841PE, 181646041PE, 181659242PE, 181661142PE, 181673143PE and 106 more |
| Model numbers | 0146-00-0097, 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, 0998-00-0800-83, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0091-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.