Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1279-2023)

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 Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

Product Classification:

Class II

Date Initiated: February 28, 2023

Date Posted: March 29, 2023

Recall Number: Z-1279-2023

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: 10

Code Information:

Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2

Distribution Pattern:

Distribution list not yet provided.

Voluntary or Mandated:

Voluntary: Firm initiated