Devices

Device Recall Maquet Datascope, Corp. Inc.

Model / Serial
Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470 Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units 0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568 Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576 Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx || An electromechanical system used to inflate and deflate intra-aortic balloons.
Manufacturer
Maquet Datascope Corp - Cardiac Assist Division
1 Event
- Recall of Device Recall Maquet Datascope, Corp. Inc.

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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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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