Enroute, which is manufactured by Cardinal Health (NYSE:CAH) subsidiary Cordis, has received a total of six product complaints between September 2020 and January 2021 involving an issue in which a tip detaches from the stent delivery system.
Additionally, test results from lots manufactured in the same time frame as those subject to the recall contributed to the decision to recall an added 48 lots with approximately 1,800 units of the system. The initial recall of five lots was initiated on Jan. 13, with the sixth complaint leading to a total of 53 lots comprising approximately 2,100 units.
The recalled units were manufactured between October 2019 and July 2020. The recall is limited to 6French crossing profile stent systems (9mm-10mm stent diameter sizes), while testing has determined that the 5French crossing profile systems (5mm-8mm stent diameter sizes) are unaffected.
Silk Road Medical has not received reports of either deaths or serious injuries, although the company acknowledged in a news release that such events could occur due to the failure mode associated with the recall.
The company said it is working to replace customer inventory with units oustide of the recalled lots, while it believes Cordis is taking steps to ensure product safety and minimal supply disruption. In collaboration with Cordis and in consultation with the FDA, Silk Road is continuing its investigation into the matter, with plans to address the recall during its fourth-quarter earnings call.