FDA Device recall Z-0091-2022
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097
- FDA Device
- Class I
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class I recall of Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097 by Datascope, citing A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0091-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-09-21 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
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
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.
Identifiers
| code_info | Battery Pack Serial Numbers: 192224349IP, 191908720IP, 202369811IP, 202791944IP, 191848115IP, 192099841IP, 192103741IP,…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, 191943120 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2022%22
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