Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1277-2023)

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 (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Product Classification:

Class II

Date Initiated: February 28, 2023

Date Posted: March 29, 2023

Recall Number: Z-1277-2023

Event ID: 91652

Reason for Recall:

There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

Status: Ongoing

Product Quantity: 391 total IABPs

Code Information:

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; Serial Numbers: CA237026J3 CH231276C6

Distribution Pattern:

Distribution list not yet provided.

Voluntary or Mandated:

Voluntary: Firm initiated