Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-2434-2023)

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 Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Product Classification:

Class I

Date Initiated: July 31, 2023

Date Posted: September 6, 2023

Recall Number: Z-2434-2023

Event ID: 92498

Reason for Recall:

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Status: Ongoing

Product Quantity: 47 units (42 US, 5 OUS)

Code Information:

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449, Model: 0998-UC-0800-75, UDI: N/A; Model: 0998-UC-0800-83, UDI: N/A; Model: 0998-UC-0800-85, UDI: N/A;

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated