Cardiosave Hybrid Intra-Aortic Balloon Pumps — Class III medical device recall Z-1907-2023
Ongoing recall by Datascope Corp., reported 2023-06-21. The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly anno
| Recall number | Z-1907-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-05-04 |
| Classified | 2023-06-14 |
| Reported by FDA | 2023-06-21 |
| Countries outside the US | DE |
| Quantity | 4 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10607567108414 |
| Serial numbers | CB283522G8, CB283804G8, CB283867G8, CB286971I8 |
| Model numbers | 0998-00-0800-55, 0998-00-0800-XX |
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Reason for recall
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
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-1907-2023. 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.