Cook Medical Recalls Two Devices That Access Blood Vessels
After 57 complaints and 14 reports of serious injury, Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select). These devices are catheters (a flexible tube) used to introduce diagnostic and therapeutic devices into a patient’s blood vessels. These products are being recalled because components of the Introducers can separate during use. If the device separates during use, it can cause life threatening adverse events. For example, the separated portion can block blood flow to vital organs or cause vessel injury and bleeding. Device separation can also result in a longer procedure time or another procedure to take out a separated piece. As previously noted, 14 people have been seriously injured due to these issues. Although no deaths have been reported to date, according to the recall, use of these devices could result in death. According to the FDA, this recall is Class I recall, the most serious type of recall. For more information regarding this recall, click here.
According to the recall notice, 37,326 devices that were distributed between May 23, 2020 and November 17, 2020 are affected by the recall. For a list of the affected devices’ catalog and lot numbers, click here. The recall notice states that Cook Medical has sent letters to affected customers, advising them to return the recalled products and to report adverse events.
If you or a loved one has been injured by a Cook Medical Flexor Check-Flo Introducer, Flexor Tuohy-Borst Side-Arm Introducer, or another medical device, the Cincinnati dangerous medical device attorneys at Burg Simpson can help. Burg Simpson has successfully represented thousands of individuals who suffered injuries due to defective products. We know what it takes to hold medical device companies responsible for their actions and secure just compensation for our clients. Call the product liability attorneys in Burg Simpson’s Cincinnati, Ohio office today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.