FDA | 合法醫療器材資訊網

2021年4月23日—TodaytheUSFoodandDrugAdministrationalertedphysicianstonewsthatCordisCorporationhasrecalledtheirPrecisePRORxcarotidstent ...

Today the US Food and Drug Administration alerted physicians to news that Cordis Corporation has recalled their Precise PRO Rx carotid stent system in the United States due to the potential for separation of the atraumatic distal tip of the sheathed delivery system.[1]

“If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke,” the FDA’s medical device recall summary stated.

There have been seven complaints related to this issue, including five reported injuries, but no reported deaths. The agency has deemed the action Class I, its most serious category.

Cordis sent out an urgent medical device recall letter to clinicians on February 11, 202...