Cardiosave Rescue Intra-Aortic Balloon Pump — Class II medical device recall Z-1230-2023
Ongoing recall by Datascope Corp., reported 2023-03-15, distributed nationwide. There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the
| Recall number | Z-1230-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-06 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 8,909 units |
| Reason classes | packaging |
| 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 Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Reason for recall
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
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-1230-2023. 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.