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HeartWare Ventricular Assist Device Recalled

Photo Credit - Drug Guardians

Weldon Stanford

- Author, Drug Guardians

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall

The Medtronic HeartWare Ventricular Assist Device (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 awaiting heart transplants. The system includes a pump implanted in the space around the heart and a controller that controls the speed and function of the pump. The HVAD is designed for use both in and out of hospital settings, including during patient transport.

Unfortunately, on June 8th, 2016, HeartWare Inc. sent an “Urgent Medical Device Correction” letter to customers who have been fitted with devices manufactured from September 30, 2014 to February 29, 2016. The letter instructed that patients be reminded of the safe use of the HVAD system, with specific mention regarding moisture and proper connection to power and data sources. Patients were instructed to inspect controllers for loose connectors by gently pressing on each connector and feeling for atypical movement.

This letter was the precursor to the nationwide recall by HeartWare Inc. of the HVAD controller due to a loose power connector which may cause the rear portion of the pumps driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, and reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death. This is not the first recall on the HVAD and is beginning to form some controversy around the risk involved with the product.

If a loose connector is identified, doctors are advised to replace with a controller from inventory and to contact their local HeartWare representative. If the loose connector is the patient’s primary controller, a careful benefit risk analysis must be performed as to whether the patient should continue using the device.

HeartWare was purchased by Medtronic for $1.1billion in August.

Legal representatives have started pursuing whether there are grounds for a class action lawsuit against HeartWare, as a result of complications as a result of the defectiveness of their product. If you would like more information on legal assistance in this regard, contact 1-800-YOURLAWYER or read more at YourLawyer.com.

Sources:

https://www.evidence.nhs.uk/Search?om=%5B%7B%22srn%22:%5B%22US%20Food%20and%20Drug%20Administration%20-%20FDA%22%5D%7D%5D&ps=30&q=back+classes&s=Relevance

http://www.massdevice.com/fda-posts-another-class-heartware-hvad-recall/

 

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