Devices

Device Recall Circulatory Support System

Model / Serial
Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
Product Description
Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. || Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
Manufacturer
Abiomed, Inc.
1 Event
- Recall of Device Recall Circulatory Support System

Manufacturer

Abiomed, Inc.

Manufacturer Address
Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923
Manufacturer Parent Company (2017)
Abiomed, Inc.
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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