FDA designates recall of support catheter as class 1
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The FDA has designated Cook Medical’s product recall of a support catheter as a class 1 recall, the most serious kind. The recall affects 117 devices manufactured and distributed between Aug. 13 and Sept. 19.
A manufacturing error of the support catheters (CrossCath), used to support a wire guide, to aid in exchanging wire guides and to gain access to a pathway for the delivery of diagnostic contrast agents or saline solutions, may result in radiopaque marker bands in certain models. The marker bands may be too loose (CXC3.0 CrossCath supporter catheters compatible with 0.014-inch wire guides) or too tight (CXC3.4 CrossCath support catheters compatible with 0.018-inch wire guides), according to a MedWatch report from the FDA. This can cause the bands to dislodge from its original position or buckle. Use of the devices may lead to the following:
- increased procedural time because of difficult advancement of the catheter through a lesion;
- increased procedural time to find a replacement;
- additional intervention to remove separated band(s); or
- additional intervention to remove a catheter that is stuck within a lesion.
If the separated marker band cannot be retrieved, patients may experience permanent impairment such as a loss of a limb or obstructed blood flow, causing life-threatening harm including stroke or death, according to the release.
Cook Medical distributed a notice to customers on Nov. 8 alerting them to examine their inventory for affected products, return them to the company and to complete an acknowledgement form regardless of whether they have affected devices.