Cook Medical issues global voluntary recall of catheters with Beacon Tip technology

Cook Medical has initiated a global, voluntary recall of all catheters with Beacon^® Tip technology. This recall includes all lots of catheters with the Beacon Tip technology. The catheters were recalled on April 15, 2016 due to complaints of tip splitting and/or fracture. The U.S. Food and Drug Administration (FDA) has not yet classified the recall. A complete list of products affected by this recall can be found below.

Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Most of the fractures and/or separations were discovered prior to patient contact. The FDA and other regulatory agencies around the world have been notified of this action.

In 2015, Cook recalled specific lot numbers of Beacon Tip catheters and then expanded that recall to all 4 French lots. Due to an increase in complaints about tip splitting and/or fracture, in April 2016 Cook has now recalled all lots and sizes to assure patient safety around the world.

“We’ve been investigating a variety of factors including environmental influences and it’s been difficult for us to reproduce the exact failures that our customers have experienced,” said Pete Yonkman, president of Cook Medical and Cook Group. “If we cannot tell our customers how to keep our products safe, then we aren’t comfortable leaving them on the market. It’s a risk we’re not willing to take. Patient safety comes first – period.”

Affected products

A full list of affected products along with Reference Part Numbers (RPNs) and Global Part Numbers (GPNs) 

Recall return information

Customers that received products affected by the recall were sent prepaid labels in a recall information packet. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected products to Cook as soon as possible for credit.

U.S. and Latin American customers can send affected products to Stericycle Expert Solutions (a third-party recall administration service).

Stericycle Expert Solutions
Phone: 1.866.201.9067
Fax: 1.888.679.5277
Email: CookMedical4674@stericycle.com

Potential adverse events

Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Adverse event reporting

Report adverse events to Cook Medical Customer Relations. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA.

Cook Medical Customer Service
Phone: 1.800.457.4500 or 1.812.339.2235, Monday – Friday between 7:30 am – 5:00 pm (EST)
Email: CustomerRelationsNA@cookmedical.com

U.S. Food and Drug Administration
Phone: 1.800.FDA.1088
Web: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

Information for Canadian customers

For information regarding this recall, please see the attached letter in English and French.