Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1232-2023)

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 Rescue. Model Number: 0998-00-0800-83.

Product Classification:

Class II

Date Initiated: February 7, 2023

Date Posted: March 15, 2023

Recall Number: Z-1232-2023

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: 47 units (44 US, 3 OUS)

Code Information:

Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

Distribution Pattern:

Nationwide US distribution. Worldwide international distribution.

Voluntary or Mandated:

Voluntary: Firm initiated