Medtronic HeartWare Ventricular Assist Device (HVAD) device caused the wrongful death of more than 3,000 people since it was introduced on the market more than 10 years ago. The sale and distribution of the heart pump was stopped in June last year but many patients still have the pump implanted in them. Now some of the batteries powering the device might be deadly too.
Medtronic announced last May that a model of battery that was powering the Medtronic HeartWare Ventricular Assist Device (HVAD) was defective and that it could cause serious personal injury or death if it was not changed for a new battery. An urgent Medical Device Correction letter was sent out by Medtronic to all affected customers on May 5th recalling 429 devices manufactured in April 2021. Then a month later, after the company received 1,159 complaints including 6 injuries and one death, the recall of the same model of batteries was extended to those that were distributed since January 2009.
The recall affects 23,372 Medtronic HVDA Batteries with model number 1650DE that were distributed between January 1st 2009 and now
These potentially defective batteries might experience electrical faults that might result in various problems such as appearing to remain charged when in use, not charging while on the battery charger or being unable to power the controller. In case the battery fails, patients who do not have the immediate possibility to change it with another working charged battery or to use AC or DC power may experience serious injury or death as the device stops to work.
Patients who still have a Medtronic HeartWare Ventricular Assist Device (HVAD) and healthcare providers with patients using such device must immediately check if their batteries or the batteries used by their patient are affected by the recall.
More information can be found in the class 1 recall issued by the FDA