A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death.
The devices are being recalled over possible interruptions in the electrical connection between power sources, including batteries, adapters and the HVAD controller, which could cause disconnection and result in possible pump stoppage.
A pump stop event could cause issues including exacerbation of heart failure symptoms and other symptoms including mild weakness, dizziness, anxiety, nausea, loss of consciousness or death, according to an FDA release.
The interruption to the electrical system is caused by oxidation of the connecting surfaces between the power source connector and the controller’s power source socket, the FDA said.
The recall affects a total of 204,017 Medtronic devices, including the HeartWare device and accessories, manufactured and distributed between March 2006 and May 2018, according to an FDA notice.
The recall affects HeartWare controllers and controller kits with model numbers 1400, 1401, 1403, 1407 and 1420, HeartWare DC adapters with model numbers 1435 and 1440, AC Adapters with model numbers 1425 and 1430 and battery packs with model numbers 1650.
Medtronic said that the recall affects 16,399 implanted HeartWare HVAD devices as of May 22, and clarified that there have been no reports of serious harm related to the recall, calculating the per-patient probability of serious adverse events at approximately 0.003.
The Fridley, Minn.-based medtech giant began notifying clinicians of the issue last month, warning that the power disconnection could cause unexpected beeping which could confuse the patient or caregiver, as the unit’s controller may still display sufficient battery capacity or AC/DC connectivity while the beeping is active.
Medtronic suggested that clinicians managing HeartWare devices reiterate the importance of having two power sources connected at all times, to reinforce best practice guidance for managing power sources when going to sleep and awakening and instructing patients to report any unexpected audible tones.
Late last month, Medtronic said it made a lubricant solution designed to be applied to the HeartWare HVAD system’s power source connectors as a method for mitigating unexpected transient power switching, which will be distributed to Medtronic HearWare field reps, according to a press release.