Cardiosave Rescue — Class II medical device recall Z-0917-2026
Ongoing recall by Datascope Corp., reported 2025-12-17, distributed nationwide. The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Serv
| Recall number | Z-0917-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2025-11-04 |
| Classified | 2025-12-11 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 47 units |
| UPC / GTIN / UDI-DI | 10607567108407 |
| Model numbers | 0998-00-0800-83 |
Product
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Reason for recall
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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-0917-2026. 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.