HeartWare Recalls Ventricular Assist System
HeartWare issued a voluntary recall of it ventricular assist system on April 29 after receiving complaints that alignment guides in the power supply connector ports might wear down over time.
If that happens, the device’s connection pins could become twisted or bent, possibly preventing patients from connecting the device controller to their system. Interruptions of the electrical connection can make the pump stop working, which could lead to serious patient injury or death.
HeartWare has received 33 reports of malfunction and one of serious injury, according to the recall notice posted Tuesday. The FDA has designated the recall a Class I.
The product codes affected, 1101 and 1103, are the same codes the devicemaker issued a voluntary Urgent Medical Device Correction for last month. In that correction, the company also warned about hazards stemming from worn alignment guides.
HeartWare recalled an older version of its ventricular assist system controllers and pump driveline splice kit in February and May, respectively. — Jason Scott