Devices

Device Recall System 98XT/98 IntraAortic Balloon Pump

Model / Serial
Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
Product Description
System 98XT/98 Intra-Aortic Balloon Pump || This product was only distributed in India and Hong Kong/China.
Manufacturer
Datascope Corporation
1 Event
- Recall of Device Recall System 98XT/98 IntraAortic Balloon Pump

Manufacturer

Datascope Corporation

Manufacturer Address
Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
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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