Home / Recalls / Datascope Corp. / Z-2438-2023

Z-2438-2023 Class I Ongoing

Recalled by Datascope Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
September 6, 2023
Initiation Date
July 31, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9175 units

Product Description

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Reason for Recall

Users were identifying autofill failure conditions on the devices causing pump stops.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

Other recalls by Datascope Corp.

  • Z-1486-2026 Class II — CS100 IABP. Software Version CS100 IABP Q.01. (January 23, 2026)
  • Z-1487-2026 Class II — CS300 IABP. Software Version CS300 IABP C.01. (January 23, 2026)
  • Z-0917-2026 Class II — Cardiosave Rescue. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0916-2026 Class II — Cardiosave Hybrid. 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-3137-2024 Class I — CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 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)