HeartWare International (NSDQ:HTWR) said today it issued a voluntary urgent medical device correction last month describing 5 complaints about its HVAD implantable heart pump.
The 1st issue involves a possible degradation of the HVAD’s internal battery, causing a loss of a “double disconnect alarm” if both power sources that connect to the pump are disconnected, the report said.
Other complaints mentioned issues with worn alignment guides leading to electrical disconnects and pump stops, accidental snags or pulls at the driveline leading to electrical issues and possible pump stops, as well as driveline outer sheath wear that may lead to exit site infection and false alarms due to loss of communication between the controller and batteries.
Last month, 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, 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.
The post HeartWare warns on HVAD issues appeared first on MassDevice.
from MassDevice http://ift.tt/1QlC0UL
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