Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2015 - (Recall #: Z-1140-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Product Classification:

Class II

Date Initiated: January 30, 2015

Date Posted: March 4, 2015

Recall Number: Z-1140-2015

Event ID: 70510

Reason for Recall:

Power supply malfunction complaints related to suboptimal thermal management.

Status: Terminated

Product Quantity: 1,300 units

Code Information:

0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

Distribution Pattern:

US Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated