The FDA today labeled a select recall of Medtronic HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I.
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.
