Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The splice kit is intended to repair the HVAD driveline, which connects the heart pump to an external controller which regulates the speed and function, if there is an electrical break, according to the FDA release.
The recall is over a design problem which could prevent the repaired cable assembly from withstanding excessive force or pulls and could cause damage to the cable assembly and interrupt electrical connections, the federal watchdog said.
Interruption in electrical connection may cause the pump to stop, which could lead to serious adverse health consequences including death, according to the FDA release.
The recall affects approximately 9 units in the US with product codes ASY00116 and ASY00281 distributed between Jan. 11, 2011 and May 23, 2014, according to the release.
Medtronic began contacting customers on March 16 about the issues, instructing health care specialists to investigate the appropriateness of driveline splice procedures given the new data.