Home / Recalls / Datascope Corp. / Z-0075-2022

Z-0075-2022 Class II Ongoing

Recalled by Datascope Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
October 13, 2021
Initiation Date
September 8, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5054 total (US), 5033 total (OUS)

Product Description

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

Reason for Recall

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Code Information

All lots

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)