HeartWare Issues Voluntary Device Correction
HeartWare International issued a voluntary Urgent Medical Device Correction last month detailing five different categories of complaints of its ventricular assist system and warning of possible hazards.
The correction, announced publicly on Monday, involves HeartWare systems with product codes 1101 and 1103. Patients and doctors are warned to consult their user manual and watch for signs of wear.
Specifically, the company says users shouldn’t disconnect the HVAD pump from both power sources at the same time, because the internal battery may degrade with age and not sound its alarm when there is a double disconnect. They should also check for worn alignment guides in the controller’s power supply connector ports and loss of communication between the controller and batteries, which can trigger false battery alarms.
In addition, users should assess the driveline outer sheath for discoloration and cracking, which could contribute to risk of infection at the exit site, and be careful when managing drivelines to avoid snagging or pulling.
Patients experiencing any of these problems should contact a doctor or a hospital VAD coordinator, the devicemaker says.
HeartWare recalled an older version of its ventricular assist system controllers and pump driveline splice kit in February and May, respectively. — Jason Scott