Cook Medical Flexor Catheter Recall Following Reports of Serious Injuries
Following dozens of complaints involving serious problems with Cook Medical Flexor catheters indicating the tubing may unexpectedly separate during use, the manufacturer recalled nearly 40,000 devices.
On December 23, the FDA announced a Cook Flexor Catheter recall was being given a class I recall classification, suggesting continued use of the product poses a risk of serious injury or death.
The action was taken after at least 57 complaints of the Cook catheters separating at a specific bonding point on the coated tubing, resulting in at least 14 incidents where patients were seriously injured. Cook Medical initially issued the recall in November, after identifying possible weak bonding sites in the coated tubing, which could result in delayed treatment and the need for emergency surgical intervention to retrieve the remaining device.
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The problems have been linked to Cook Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers with a coated shaft, a valve, a dilator, and markers that show up on an x-ray to allow physicians to insert medical devices used for therapy or diagnosis into the vessels.
In the event of a tubing separation during a procedure, patients could be at the increased risk of blood flow being blocked to vital organs, vessel injury, and severe bleeding events, the FDA and Cook Medical warn. Patients could experience delays in the intended therapeutic procedure while emergency surgery is performed to retrieve the separated catheter, posing life-threatening adverse events.
Approximately 37,326 Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers manufactured by Cook Medical of Bloomington, Indiana, from February 17, 2020 to September 29, 2020 may experience the problems. The devices were distributed to hospitals and healthcare facilities from May 23, 2020 to November 17, 2020.
Cook Medical sent an Urgent Medical Device Recall notification on November 24, instructing customers to immediately remove all of the impacted catheters from their inventory, and to return the products to cook Medical with a copy of the acknowledgement and receipt forms.
Following the reported injuries, the FDA gave this recall as a Class I designation last week, indicating there is a reasonable probability the use of the product will cause serious adverse health consequences or death.
Customers with additional questions are being encouraged to contact Cook Medical by phone at 800-457-4500 or 812-339-2235 or by emailing the company at CustomerRelationsNA@CookMedical.com.
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