Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1230-2023)

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 Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85

Product Classification:

Class II

Date Initiated: February 7, 2023

Date Posted: March 15, 2023

Recall Number: Z-1230-2023

Event ID: 91645

Reason for Recall:

There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.

Status: Ongoing

Product Quantity: 8909 units

Code Information:

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

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated