FDA recall Z-0100-2019

Maquet Datascope Corp - Cardiac Assist Division · Class I · device

Product

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

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

US Nationwide; Internationally to 77 countries

Key facts

Status: Ongoing
Initiation date: 2018-09-20
Report date: 2018-11-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2019