Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-1386-2017

Z-1386-2017 Class II Terminated

Recalled by Maquet Datascope Corp - Cardiac Assist Division — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
March 8, 2017
Initiation Date
December 23, 2016
Termination Date
March 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8000

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

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.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

part number 0146-00-0097

Other recalls by Maquet Datascope Corp - Cardiac Assist Division

  • Z-0099-2019 Class I — Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 (September 20, 2018)
  • Z-0100-2019 Class I — Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 (September 20, 2018)
  • Z-1928-2018 Class I — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX (May 3, 2018)
  • Z-3086-2017 Class I — CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by i (July 17, 2017)
  • Z-3085-2017 Class I — CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by (July 17, 2017)
  • Z-3087-2017 Class I — CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by i (July 17, 2017)
  • Z-2736-2017 Class I — CS 100i Intra-Aortic Balloon Pump (June 16, 2017)
  • Z-2738-2017 Class I — CS 300 Intra-Aortic Balloon Pump (June 16, 2017)
  • Z-2737-2017 Class I — CS 100 Intra-Aortic Balloon Pump (June 16, 2017)
  • Z-1248-2016 Class II — Cardiosave Hybrid and rescue IABP (December 16, 2015)