Cardiosave Rescue Intra-Aortic Balloon Pump — Class I medical device recall Z-0886-2023

Ongoing recall by Datascope Corp., reported 2023-01-25, distributed nationwide. The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is pr

Recall number	`Z-0886-2023`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Datascope Corp., Mahwah, NJ, United States
Recall initiated	2022-12-19
Classified	2023-01-19
Reported by FDA	2023-01-25
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, 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
Quantity	46 total
UPC / GTIN / UDI-DI	`10607567108407`, `10607567112312`, `10607567113449`
Model numbers	`0998-00-0800-75`, `0998-00-0800-83`, `0998-00-0800-85`, `0998-UC-0800-75`, `0998-UC-0800-83`, `0998-UC-0800-85`, `D998`

Product

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

Reason for recall

The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.

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-0886-2023. 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.