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Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected par
Recalled March 8, 2017 · FDA recall Z-1386-2017 · Maquet Datascope Corp - Cardiac Assist Division
Hazard
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped. · FDA Class II
Units
8000
Sold at
Worldwide Distribution - US Nationwide
Description
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Product
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →