The U.S. Food and Drug Administration (FDA) has identified a Class I recall of Cook Medical’s CrossCath Support Catheter. A Class I recall is the most serious type of recall, as use of these devices may cause serious injuries or death.
CrossCath Support Catheters are designed to support a wire guide during access of blood vessels, allow for exchange of wire guides and provide a pathway for the delivery of saline solutions or diagnostic contrast agents. The catheters have three radiopaque markers spaced equally along the catheter to aid in estimating lengths within the blood vessels (vascular system).
Cook Medical has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014” wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018” wire guides). Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.
Use of the affected product can cause increased procedural time to obtain a replacement, increased procedural time due to difficult advancement of the catheter through a lesion, additional intervention to remove a catheter that becomes stuck within a lesion, additional intervention to remove separated marker band(s). There is also the potential that the separated marker band cannot be retrieved, and it can cause permanent impairment like loss of limb; or the fragment can obstruct blood flow (embolize), resulting in life-threatening harm (e.g., stroke), or death.
