HeartWare International (NSDQ:HTWR) issued a field notice on its HVAD implantable heart pump over issues with worn alignment guides and connection pins that could lead to the pump stopping, according to the FDA.
The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watch dog, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall, issued April 29 and posted today, affects all HeartWare systems with product codes 1101 and 1103, manufactured and distributed between January 2008 and March 2015, according to the FDA. A total of 1,763 units are potentially affected by field notice.
According to the FDA recall, “the alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death.”
Heartware has reported 33 cases of malfunction and 1 serious injury related to this problem, the FDA states. HeartWare plans to replace all defective controllers by the end of June 2016.
Last week, Framingham, Mass.-based HeartWare said it had issued a voluntary urgent medical device correction describing 5 complaints about its HVAD implantable heart pump. One complaint was issues with worn alignment guides leading to electrical disconnects and pump stops.
In May, Heartware recalled of 35 HVAD repair kits in an FDA Class I recall over the risk of failures when the device is exposed to excessive force. In February, HeartWare issued an urgent recall of computerized controllers for the HVAD pump, over concerns that they may malfunction and stop the device.