Devices

Device Recall AB5000 Portable Driver

Model / Serial
Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
Product Description
Abiomed AB5000 Portable Driver || Catalog number: 0025-0000 || The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
Manufacturer
Abiomed, Inc.
1 Event
- Recall of Device Recall AB5000 Portable Driver

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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