FDA Alerts

Class 1 Recall: HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls

Class 1 Recall: HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls

Mon Jun 29 2015By Jonathan Payne

Recall Class: Class I

Dates Recall Initiated: April 29, 2015

Device: HeartWare Ventricular Assist Device (HVAD)

  • Product Codes: 1101, 1103
  • Serial Numbers: All Heartware systems currently in use
  • Manufacturing and Distribution Dates: January 2008 to March 2015
  • Devices recalled in the US: 1763

Use: The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.

Recalling Firm:
HeartWare
14400 NW 60th Avenue
Miami Lakes, Florida, 33014

Reasons for Recalls:

Heartware recently conducted five recalls for this device. They are all outlined in the firm’s June 8, 2015 press release . The FDA will update this page as new information becomes available.

 

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