FDA Issues Update on Cook Medical Catheter Recall
The FDA has issued on update on Cook Medical’s recall of two of its catheter products, designated as a Class I recall because use of the devices could lead to serious injury or death.
The company initiated the recall of its Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers in late November, noting that they have an increased risk of separating during surgical procedures. In total, the firm recalled 37,326 devices.
“Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury and bleeding,” the agency said.
While there have been no reported deaths, there have been 57 complaints and 14 reports of serious injuries stemming from the issue, the FDA said.