FOR IMMEDIATE RELEASE: August 3, 2015
Cook Incorporated
750 Daniels Way, P.O. 489
Bloomington, Indiana 47402
812.339.2235
www.cookmedical.com
Purpose of the Press Release:
On July 2, 2015, Cook Medical 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 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 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.
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.
The Beacon Tip Angiographic Catheters in this recall were distributed between June 2013 and June 2015. 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 here.
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.
FDA and other regulatory agencies around the world have been notified of this action.
Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@cookmedical.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.