Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump

Model / Serial
IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and approximately 104 countries.
Product Description
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Manufacturer
Maquet Datascope Corp - Cardiac Assist Division
1 Event
- Recall of Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division

Manufacturer Address
Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA

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