Cook Medical Issues Global Recall of Beacon Tip Angiographic Catheter Products
August 4, 2015—Cook Medical advised that on July 2, 2015, the company initiated a lot-specific voluntary recall of 2,239 lots of Beacon tip angiographic catheters. Globally, 95,167 devices are subject to this recall.
The US Food and Drug Administration and other regulatory agencies around the world have been notified of this action. Additionally, Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.
The products include specific versions and lot numbers of the Torcon NB Advantage Beacon tip catheters (catalog prefix HNBR5.0), Royal Flush Plus Beacon tip high-flow catheters (catalog prefix HNR4.0), and Slip-Cath Beacon tip catheters (catalog prefix SCBR5.0).
The Beacon tip angiographic catheters in this recall were distributed between June 2013 and June 2015. The product can be identified by the part number and lot number provided on the outer-package product label. The lot numbers for products that are subject to this recall can be found on the company’s website.
Cook Medical stated that the Beacon tip angiographic catheters have been found to exhibit tip splitting or separation, which has resulted in adverse events. Cook has received 26 complaints of catheter-tip splitting and/or separation. There have been 14 Medical Device Reports to date in which a tip split or separation occurred.
The company noted that tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.