Cardiosave Hybrid Intra-Aortic Balloon Pumps — Class I medical device recall Z-1145-2023
Ongoing recall by Datascope Corp., reported 2023-03-15, distributed nationwide. An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable
| Recall number | Z-1145-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-09 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CZ, DE, EC, EG, ES, FI, FR, GB, GH, HK, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, MA, MX, MY, NG, NL, NO, OM, PH, PK, PL, PT, RS, RU, SA, SE, SG, SK, SV, TH, TR, TT, TW, VN, ZA |
| Quantity | 4,062 total |
| UPC / GTIN / UDI-DI | 10607567108391, 10607567108414, 10607567108421, 10607567108438, 10607567109008, 10607567109053, 10607567109107, 10607567111117, 10607567111940, 10607567113432 |
| Model numbers | 0012-00-1801, 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53 |
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55
Reason for recall
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
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-1145-2023. 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.