Cook Medial Recalls Thousands Of Defective Medical Devices
The U.S. Food and Drug Administration (FDA) announced that Cook Medical issued an immediate recall of two commonly used medical devices. The recall involves Cook Medical’s Flexor Check-Flo Introducers and the Flexor Tuohy-Borst Side-Arm Introducers. Cook says they have an increased risk of separating during use.
According to the FDA, on November 24, 2020, Cook Medical sent an Urgent Medical Device Recall notification letter to customers. In this letter, Cook let them know the company is removing all devices potentially affected from the market.
The FDA considers places this recall into the Class 1 category, the most serious type of recall. In its announcement the agency stated that “use of these devices may cause serious injuries or death.”
What Are the Flexor Check-Flo Introducers and the Flexor Tuohy-Borst Side-Arm Introducers Used For?
Both devices made by Cook Medical are introducers, also known as catheters. They are made up of various parts including a coated shaft, dilator, valve, and markers which allow them to be seen on x-rays. The introducers are used to help guide doctors as they insert other diagnostic medical devices into the body’s vessels during surgery. These devices are not used in brain or heart vessels.
Why Are Cook Medical’s Introducers Being Recalled?
Cook Medical is recalling the devices because there is an increased risk of separation at what it calls the “proximal bond site.” If it does separate, the results can lead to life-threatening adverse events. Adverse events can include:
- longer procedure time
- another procedure to take out a separated piece
- blocking blood flow to vital organs
- vessel injury
There have been nearly 60 complaints about these devices and 14 reports of serious adverse events/injuries. No deaths have been reported as of the announcement of the recall.
More than 37,000 devices in the US are part of this class 1 recall. This recall can have serious implications for patients who received the affected medical devices as well as medical centers and doctors who use them. For more specifics about the recall and contact information go to:
Call Alonso Krangle If You Have Been Injured by a Cook Medical Catheter
At Alonso Krangle, LLP, our lawyers have been helping victims fight for their legal rights when negligence causes them to suffer serious injuries. Our practice includes filing claims for victims related to dangerous medical devices, as well as motor vehicle accidents, nursing home abuse and neglect, slip and fall injuries, and other accidents that result in injuries.
Call us today at 800-403-6191 or 516-350-5555 if you have been injured and want to learn more about how we can help you collect the damages you deserve.