Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2014 - (Recall #: Z-1523-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

Product Classification:

Class I

Date Initiated: March 21, 2014

Date Posted: May 28, 2014

Recall Number: Z-1523-2014

Event ID: 67815

Reason for Recall:

Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.

Status: Terminated

Product Quantity: 11,881 units (US 5183 and OUS 6698)

Code Information:

IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and approximately 104 countries.

Voluntary or Mandated:

Voluntary: Firm initiated