Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1231-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.

Product Classification:

Class II

Date Initiated: February 7, 2023

Date Posted: March 15, 2023

Recall Number: Z-1231-2023

Event ID: 91642

Reason for Recall:

Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

Status: Ongoing

Product Quantity: 11,792 units (5.408 US, 6,384 OUS)

Code Information:

Model Number (UDI-DI): D998-00-0800-31 (10607567109053¿), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-00-0800-83 (10607567108407), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414). All serial numbers

Distribution Pattern:

Nationwide US distribution. Worldwide international distribution.

Voluntary or Mandated:

Voluntary: Firm initiated