Maquet Datascope Corp - Cardiac Assist Division: Medical Device Recall in 2017 - (Recall #: Z-1386-2017)

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:

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

Product Classification:

Class II

Date Initiated: December 23, 2016

Date Posted: March 8, 2017

Recall Number: Z-1386-2017

Event ID: 76052

Reason for Recall:

Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

Status: Terminated

Product Quantity: 8000

Code Information:

part number 0146-00-0097

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated