Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2017 - (Recall #: Z-2737-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

CS 100 Intra-Aortic Balloon Pump

Product Classification:

Class I

Date Initiated: June 16, 2017

Date Posted: August 2, 2017

Recall Number: Z-2737-2017

Event ID: 77566

Reason for Recall:

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Status: Terminated

Product Quantity: 12,319 units total

Code Information:

0998-XX-3013-XX, 0998-UC-3013-XX

Distribution Pattern:

Worldwide Distribution - (in over 100 countries) US (Nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated