FDAnews Device Daily Bulletin
Quality / Medical Devices / Postmarket Safety / Commercial Operations

Cook Medical Issues Recall of Beacon Tip Angiographic Catheter Products

Aug. 5, 2015

Cook Medical, a manufacturer of minimally invasive medical devices, announced that it has issued a voluntary global recall of 2,239 lots of Beacon Tip Angiographic Catheter products. The recall was initiated on July 2, 2015, and a total of 95,167 devices are subject to the recall.

The devices have been found to exhibit tip splitting or separation, resulting in the Indiana-based Cook receiving 26 complaints.

Tip splitting can result in a device becoming dysfunctional, while tip separation can close off blood flow to end organs. To date, there have been 14 Medical Device Reports that have documented a tip split or separation.

Cook’s customers, along with the FDA and other regulatory agencies around the world have been alerted of the recall. — Michael Cipriano