Flexor Check-Flo

2020: Recall over 50,000 defective Flexor Check-Flo catheters

In early December 2020, Cook Medical began a voluntary recall of nearly 59,000 catheters designed to introduce therapeutic or diagnostic devices into the vasculature, with the exception of coronary and neurovascular vessels. No injuries have yet been reported due to the use of defective catheters.

Flexor Check-Flo introduser and Flexor Tuohy-Borst introduser (Shuttle Select) are sterile disposable devices consisting of a rod with a hydrophilic coating of various stiffness and distal radiopaque markers. The review covers certain batches of 4-9 Fr Flexor Check-Flo (highly elastic Ansel) and 5 and 6 Fr Flexor Shuttle Select introducers, a total of 58,499 units worldwide.

Cook Medical recalls over 50,000 defective Flexor Check-Flo catheters

The notice states that Cook Medical received 9 reports of separation of the hydrophilic coating from the rod during use. Exposing the rod during the procedure can lead to life-threatening undesirable consequences. Among other possible side effects include increased procedure time, the need for additional intervention to extract the separated catheter segment, embolization that prevents blood supply to the vital organ, as well as vessel damage and bleeding.

Cook Medical recalls catheters without a regulatory reminder "from precautions and as a sign of support for physicians and patients," company spokeswoman Hannah Chudleigh explained in an email to Medical Tubing + Extraction.

We received 4 reports of additional intervention to extract separated catheter segments. There were no reports of injuries, such as embolization blocking blood flow to a vital organ, vascular damage, bleeding or death of the patient, she added.[1]

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