FDA designates recall of HVAD batteries as class I
The FDA has designated Medtronic’s recall of its ventricular assist device batteries due to electrical faults causing battery failure as class I, the most serious type.
According to an FDA press release, the device batteries (Heartware ventricular assist device [HVAD]) may experience electrical faults and cause the system to unexpectedly fail, rendering it unable to power the controller, accept charge from the battery charger or remain charged when in use.
The company reports receiving 1,159 complaints, six injuries and one death attributable to this issue.
The recall affects 23,372 devices distributed from 2009 to present, according to the release.
As Healio previously reported, Medtronic issued an urgent medical device correction to inform health care providers of the defect in these devices in April 2022, and the FDA issued a letter to health care providers.
Later, in June, the FDA labeled the single-lot recall of these batteries distributed from April 20 to July 19, 2021, as class I. The company identified welding defects that could cause the two cell battery packs needed to power the device to separate. According to a company release, affected devices may fail to charge or lose power entirely.
If this malfunction occurs, it will trigger a power disconnect alarm on the controller screen and in the “alarm log” tab of the HVAD monitor, the company stated. These alarms may resolve, but the battery will continue to fail, according to the release.
The company reported one death and two complaints associated with the recalled batteries.
The FDA also previously labeled the recall of the company’s ventricular assist device implant kit due to a pump weld defect as class I.
Following an inspection of explanted pumps, the company reported it found moisture in the center post of the pump, causing corrosion and demagnetization of the internal magnets. This may result in pump malfunction, death, severe injury or the need for major pump replacement surgery.
According to an FDA press release, patients with affected devices may present with signs and symptoms that resemble pump thrombosis.
The affected devices include 1,614 HVAD implant kits distributed between Oct. 11, 2006 and June 3, 2021.
The company reports it received three complaints regarding this device issue, including one death and two injuries.
Editor’s Note: This article was updated Aug. 25, 2022, with information on the battery recall.