HeartWare International (NSDQ:HTWR) last week issued a recall for driveline splice kits used to repair its HVAD left ventricular assist device, citing concerns over the risk of failures when the device is exposed to excessive force.
Thirty-five of the repair kits were distributed internationally and in Florida, Kentucky, Missouri, New York, Tennessee and Texas, according to the FDA, which slapped Class I status on the recall. A Class I recall denotes the risk of serious injury or death.
The recall covers catalog number ASY00281 and ASY00116 splice kits, intended to repair driveline cables should an electrical break occur, the safety watchdog said.
In February, Framingham, Mass.-based HeartWare issued an urgent recall of computerized controllers for the HVAD pump, over concerns that they may malfunction and stop the device.
The recalled devices were implanted pre-FDA approval of the device in 2012, during HeartWare’s Advance and Endurance clinical trials. Approximately 120 U.S. patients were affected by the previous recall.
In 2013, HeartWare issued a field safety correction action for the same devices, citing electrostatic concerns. Since then, electrostatic discharge has been implicated in the death of 1 patient and the serious injury of another, according to the company.