Cardiosave Rescue IABP — Class I medical device recall Z-0100-2019
Ongoing recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2018-11-07, distributed nationwide. There is a potential for interruption and/or inability to start therapy to the patient prior to or during use
| Recall number | Z-0100-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, United States |
| Recall initiated | 2018-09-20 |
| Classified | 2018-10-26 |
| Reported by FDA | 2018-11-07 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10607567108407 |
| Model numbers | 0998-UC-0800-83 |
Product
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Reason for recall
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
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-0100-2019. 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.