FDA says Cordis carotid artery stent recall is serious

The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall.

Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients.

The Precise Pro Rx is used to treat patients with narrowed carotid arteries and includes a metal (nitinol) self-expanding stent that is preloaded on a delivery catheter used to place the stent.

According to an FDA release, if the device separates during use, it may cause serious adverse events, such as the removal of the separated tip from the carotid artery, embolization distally or stroke.

To date, there have been seven complaints about the issue with the Precise Pro Rx carotid stent system. Five injuries were reported, although no deaths have been registered as a result of the issue to date.

Affected products were manufactured…

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Silk Road Medical issues voluntary recall of Enroute transcarotid stent system

Silk Road Medical (NSDQ:SILK) announced today that it is voluntarily recalling additional lots of its Enroute transcarotid stent system.

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 …

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