Datascope Corp.: Medical Device Recall in 2021 - (Recall #: Z-2616-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Product Classification:

Class II

Date Initiated: September 8, 2021

Date Posted: October 6, 2021

Recall Number: Z-2616-2021

Event ID: 88664

Reason for Recall:

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

Status: Ongoing

Product Quantity: 3969 total (US); 3550 total (OUS)

Code Information:

All lots

Distribution Pattern:

Nationwide domestic distribution. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated