FDA.gov – Class I Recall – Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling.
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.
The CrossCath® Support Catheters are designed to support a wire guide during access of blood vessels, allow for an 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).