Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-1248-2016

Z-1248-2016 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
April 6, 2016
Initiation Date
December 16, 2015
Termination Date
June 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1243 units US; 1107 units OUS

Product Description

Cardiosave Hybrid and rescue IABP

Reason for Recall

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

Distribution Pattern

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Code Information

Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

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-3087-2017 Class I — CS 300 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-3086-2017 Class I — CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by i (July 17, 2017)
  • Z-2737-2017 Class I — CS 100 Intra-Aortic Balloon Pump (June 16, 2017)
  • Z-2738-2017 Class I — CS 300 Intra-Aortic Balloon Pump (June 16, 2017)
  • Z-2736-2017 Class I — CS 100i 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)