Cook Medical Inc. is recalling its 117 support catheter devices in the U.S., covering six lots that were manufactured between Aug. 13 and Aug. 16.
The U.S. Food and Drug Administration identified it as a Class I recall, the most serious type of recall.
The company's CrossCath Support Catheters are used to support a wire guide during access to 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, which help to estimate lengths within the blood vessels.
The Bloomington, Ind.-based private medical-equipment maker initiated the recall Nov. 8, after identifying an error during manufacturing that may cause the radiopaque marker bands to be too loose or too tight. Marker bands that are too loose can dislodge from their original position, and the ones 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, and additional intervention to remove separated marker band.
In addition, the use of the devices carries 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, resulting in life-threatening harm or death.