The FDA has labeled Medtronic’s recall of its HeartWare Ventricular Assist Device (VAD) system as Class I, indicating a reasonable risk of serious injury or death. The electrical connection between the system’s power source—the battery, AC adapter or DC adapter—and the VAD controller may be interrupted due to oxidation on the connecting surfaces, according to the agency’s recall notice.
“Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop,” the notice stated. “A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness or death.”
Medtronic said in a June 1 press release there have been no confirmed reports of catastrophic harm related to this issue. The company alerted clinicians in May to the problem, saying it “may result in unintended power switching to the secondary power source and/or unexpected audible tones (‘beeping’).”
Ninety-seven percent of these instances result in no symptoms, according to Medtronic, and a patient’s probability of experiencing serious adverse health consequences due to this issue is 0.003.
Medtronic recommended clinicians follow these instructions:
- Reinforce the importance of keeping two power sources connected.
- Ensure two power sources are fully charged when going to sleep and awakening.
- Instruct patients to report any “persistent, unexpected” audible tones to the VAD team for additional instructions.
The recall affects 204,017 devices in the U.S. manufactured and distributed from March 2006 to May 2018, according to the FDA.