Cardiosave Rescue Intra-Aortic Balloon Pump — Class I medical device recall Z-2150-2023

Ongoing recall by Datascope Corp., reported 2023-07-26, distributed nationwide. IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batterie

Recall number	`Z-2150-2023`
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	2023-07-19
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

IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to 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-2150-2023. 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.