Home / Recalls / Datascope Corp. / Z-2431-2023

Z-2431-2023 Class I Ongoing

Recalled by Datascope Corp. — Mahwah, NJ

FDA device recall Z-2431-2023 was initiated by Datascope Corp. on July 31, 2023 and is designated Class I. Reason for recall: Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the cons… The recall status is ongoing. Affected quantity: 9175 units.

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 Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Reason for Recall

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; 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-1587-2026 Class III — Battery Charging Station; Model: 0998-00-0802; (February 6, 2026)
  • 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-3136-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3135-2024 Class I — CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)

FDA data resources