FDA-Device2017-03-08Class II
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
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.
Sold states
Worldwide Distribution - US Nationwide
Affected count
8000
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2017Don't want to check this manually?
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