Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-1140-2015

Z-1140-2015 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 4, 2015
Initiation Date
January 30, 2015
Termination Date
September 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,300 units

Product Description

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Reason for Recall

Power supply malfunction complaints related to suboptimal thermal management.

Distribution Pattern

US Nationwide distribution

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.

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-1386-2017 Class II — CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998- (December 23, 2016)