FDA: Class I Recall for Cook Medical’s CrossCath Support Catheters

Cook Medical is recalling its CrossCath support catheters due to a manufacturing error that could cause the radiopaque marker bands to separate from the catheter if they are too loose or cause buckling if too tight. The US Food and Drug Administration announced today that it has deemed it a Class I device recall, the most serious type.

The recall affects six lots of the CrossCath device that were distributed between September 03, 2019, and September 19, 2019 (9945302, 9945303, 9953512, 9945301, 9950878, 9953506). In total, Cook Medical estimates that 117 devices “currently in commerce” are affected by the manufacturing error.

The catheters are used to support a guidewire during cardiac or peripheral access of vessels, allow for exchange of guidewires, and serve as a pathway for the delivery of saline or diagnostic contrast agents. Each catheter has three radiopaque marker bands spaced at equal intervals to aid operators in estimating vessel lengths.

Use of the defective catheters can prolong procedure time due to the need to replace the catheter or because of difficulty in passing it through a lesion. It also could result in the need for an additional procedure to remove marker bands that dislodge and become stuck within a lesion. The recall notice states that there is a possibility that a separated marker band might not be retrievable, resulting in permanent impairment that could include loss of a limb or life-threatening complications such as stroke or death due to embolization.

Cook Medical issued an Urgent Medical Device Recall November 8, 2019, with instructions for examining and returning affected devices.