Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall.
Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support Catheters. If the marker bands are too loose, they can dislodge from their original position and marker bands that are too tight can cause buckling.
Using the catheters can cause increased procedural time to get a replacement, increased procedural time due to difficult advancement of a catheter through a lesion, intervention to remove a catheter that becomes stuck in a lesion and additional intervention to remove separated marker bands. The catheters also run the risk of causing permanent impairment if a separated marker band cannot be retrieved, which can include loss of limb or fragments can obstruct blood flow and cause stroke or death.
The CrossCath Support Catheters being recalled include model numbers CXC3.0-1.9-14-90-P-NS-0, CXC3.4-2.2-18-90-P-NS-0, CXC3.4-2.2-18-135-P-NS-0 and CXC3.4-2.2-18-150-P-NS-0 in lot numbers 9945302, 9945303, 9953512, 9945301, 9950878 and 9953506. They were distributed from Sept. 3 to Sept. 19.
Interventional cardiologists, radiologists and surgeons who use the CrossCath Support Catheter may be affected by the Class I recall. Patients who are receiving cardiac surgery using the catheter could also be affected, according to the FDA. No adverse events have been reported.
Cook Medical recommends examining inventory immediately to determine if you have the product and quarantine any affected products that are unused. The company also recommends returning the affected products with a copy of Acknowledgement and Receipt to receive a product credit. Cook Medical also said to complete the Acknowledgement and Receipt Form and return it even if physicians do not have the affected products on hand.