Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-2738-2017

Z-2738-2017 Class I Terminated

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

Recall Details

Product Type
Devices
Report Date
August 2, 2017
Initiation Date
June 16, 2017
Termination Date
November 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,319 units total

Product Description

CS 300 Intra-Aortic Balloon Pump

Reason for Recall

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Distribution Pattern

Worldwide Distribution - (in over 100 countries) US (Nationwide)

Code Information

0998-XX-3023-XX 0998-UC-3023-XX

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-2736-2017 Class I — CS 100i 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)
  • Z-1248-2016 Class II — Cardiosave Hybrid and rescue IABP (December 16, 2015)