Cardiosave Rescue Intra-Aortic Balloon Pumps — Class II medical device recall Z-2487-2023
Ongoing recall by Datascope Corp., reported 2023-09-06, distributed nationwide. Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aor
| Recall number | Z-2487-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-07-31 |
| Classified | 2023-08-30 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 9,379 units |
| UPC / GTIN / UDI-DI | 10607567108407, 10607567112312, 10607567113449 |
| Model numbers | 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 |
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason for recall
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
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-2487-2023. 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.