The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious.
Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail.
A similar recall of just one lot of 429 batteries (model number 1650DE) was issued on June 23 and reported in the June 27 ORam. At that time, Medtronic reported one death and two complaints associated with the affected lot.
This recall includes 23,372 batteries (model number 1650DE). At this time, Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.
Medtronic has added to the “Information for Patients and Health Care Providers: HVAD System” section about useful life and inspection for HVAD System components.
Distribution dates were January 1, 2009 to present.Read More >>