FDA: Another Class I Recall for HeartWare VAD
This time, controller port damage may prevent power and data cables from connecting, leading to a full or partial pump stop.
The US Food and Drug Administration is alerting physicians to another Class I recall for the HeartWare ventricular assist device (HVAD), this time related to controller port damage. The FDA alert, following a recall initiated by the company February 26, 2021, comes less than 2 months after the company issued a recall for its HeartWare VAD pump implant kit.
The FDA alert yesterday warns that Medtronic is now recalling HVAD battery cables, data cables, adapter cables and controller 2.0 ports “because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the controller port metal pins.” Bent pins, for example, could result from the wear and tear, the agency says. “Damaged controller ports may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump. This could cause serious patient harm including loss of consciousness, hospitalization, heart attack, or death.”
The problem has resulted in the deaths of 12 patients, as well as eight reports of injury and 855 complaints.
The company sent an urgent medical device notice to physicians back in late February instructing them to read enclosed updated information pertaining to the frequency of device inspections. During inspections, physicians should pay particular attention to scratches on the plug face; surface irregularity, dents, chips, or cracks on the connector plugs; and dents, chips, or cracks in the cables. Additional information is provided for patients.
Affected devices include those manufactured any time after March 7, 2006; affected product numbers are listed in the recall.
The last HeartWare recall, in March, related to the pump implant kit, warned that devices may fail to start or restart after stoppage, or only restart after a delay, thus putting patients at risk of MI, heart failure, or death. Last year in May, the company issued a recall warning of pump outflow graft tears and breaks of the strain relief screws.
US Food and Drug Administration. Medtronic recalls HeartWare HVAD battery cables, data cables, adapter cables and controller 2.0 ports due to risk of damage to controller ports. Published on: April 15, 2021. Accessed on: April 16, 2021.