Home / Recalls / Maquet Datascope Corp - Cardiac Assist Division / Z-0099-2019

Z-0099-2019 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
November 7, 2018
Initiation Date
September 20, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Reason for Recall

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Distribution Pattern

US Nationwide; Internationally to 77 countries

Code Information

UDI - 10607567108391 All Serial Numbers

Other recalls by Maquet Datascope Corp - Cardiac Assist Division

  • 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-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-3087-2017 Class I — CS 300 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)
  • Z-1248-2016 Class II — Cardiosave Hybrid and rescue IABP (December 16, 2015)