Medtronic recalled 6,912 units of the EnVeo R loading systems after receiving two reports of particulates in packaged kits and six reports of particulates in the loading bath during valve loading as of July 6.
The company announced it had found no other adverse effects, and the issue does not effect other Medtronic devices or components of its Evolut R device. On June 23, the FDA approved the Evolut R, which is used to treat patients with severe aortic stenosis.
Of the effected units, 540 were distributed in the U.S., according to Medtronic.
“Presence of particulate in the EnVeo R Loading System has the potential to be transferred to the Transcatheter Aortic Valve (TAV) and released into the patient’s vasculature after deploying the TAV,” Medtronic wrote in a letter. “If this were to occur, potential harms may include embolism into the bloodstream. While Medtronic has received only eight reports of particulate identified from the loading system, with no reports of patient adverse effects, bench testing has demonstrated a higher prevalence of particulate and the potential for its transfer to the TAV.”