Devices

Device Recall Impella 5.0 Circulatory Support System

Model / Serial
Serial numbers: 45921,45922,45923,45924
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
International only: Canada and France
Product Description
Impella 5.0 Circulatory Support System || Catalog number: 004840 || The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
Manufacturer
Abiomed, Inc.
1 Event
- Recall of Device Recall Impella 5.0 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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