FDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level.
Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The Flexor devices involved in the recall have an increased chance of separating at a specific point, the proximal bond site, FDA said last week in its announcement of the Class I designation.
FDA said there have been 57 complaints about the problem, with 14 reports of serious injuries. There are no reported deaths.
Cook Medical in its Urgent Medical Device Recall notification letter told health providers to return the devices and immediately report adverse events to the Bloomington, Ind.–based company’s medical customer relations.
The Flexor introducers involved in the recall were made between Feb. 17 and Sept. 29, and distributed between May 23 and Nov. 17.