Cardiosave Rescue Intra-Aortic Balloon Pump — Class I medical device recall Z-2152-2023
Ongoing recall by Datascope Corp., reported 2023-07-26, distributed nationwide. An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Bo
| Recall number | Z-2152-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-06-05 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, 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, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, VN, ZA |
| UPC / GTIN / UDI-DI | 10607567108407, 10607567112312, 10607567113449 |
| Model numbers | 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 10607567108407, 10607567112312, 10607567113449 |
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Reason for recall
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
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-2152-2023. 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.