Cook Medical Beacon® Tip Centimeter Sizing Catheter

Issue

Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples had underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check. This issue has been isolated to specific supplier lots of these marker bands.