Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-1907-2023)

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 Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Product Classification:

Class III

Date Initiated: May 4, 2023

Date Posted: June 21, 2023

Recall Number: Z-1907-2023

Event ID: 92214

Reason for Recall:

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

Status: Ongoing

Product Quantity: 4 units

Code Information:

UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8

Distribution Pattern:

International distribution in the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated