Home / Recalls / Datascope Corp. / Z-1907-2023

Z-1907-2023 Class III Ongoing

Recalled by Datascope Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
June 21, 2023
Initiation Date
May 4, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Reason for Recall

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

Distribution Pattern

International distribution in the country of Germany.

Code Information

UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8

Other recalls by Datascope Corp.

  • Z-1587-2026 Class III — Battery Charging Station; Model: 0998-00-0802; (February 6, 2026)
  • Z-1487-2026 Class II — CS300 IABP. Software Version CS300 IABP C.01. (January 23, 2026)
  • Z-1486-2026 Class II — CS100 IABP. Software Version CS100 IABP Q.01. (January 23, 2026)
  • Z-0916-2026 Class II — Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0917-2026 Class II — Cardiosave Rescue. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0931-2026 Class III — Cardiosave Hybrid (October 23, 2025)
  • Z-0932-2026 Class III — Cardiosave Rescue (October 23, 2025)
  • Z-0311-2025 Class II — MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0 (September 17, 2024)
  • Z-3134-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3136-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)