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.”
|Product Brand Name||Catalog Identifier *||Lot Number|
|Beacon® Tip Torcon NB® Advantage Catheter||HNBR5.0
|Beacon® Tip Royal Flush® Plus High-Flow Catheter||HNR5.0||All lots|
|Beacon® Tip Centimeter Sizing Catheter,
Beacon® Tip White Vessel Sizing Catheter,
Beacon® Tip Vessel Sizing Catheter
|Shuttle® Select Slip-Cath||SCBR5.5-/-SHTL
|Slip-Cath® Beacon® Tip Catheter||SCBR5.0
|FluoroSet® Radiographic Tubal Assessment Set||J-RTAS-100||All lots|
|Haskal Transjugular Intrahepatic Portal Access Set||HTPS||All lots|
|Kumpe Access Catheter||023565-BT||All lots|
|Liver Access and Biopsy Needle Set||LABS||All lots|
|Neff D’Agostino Percutaneous Access Set||NPAS-100-D’Agostino-B-050393||All lots|
|Aprima™ Access Nonvascular Introducer Set||NPAS-/-SST
|Selective Salpingography Catheter with Beacon® Tip||J-SSG-504000||All lots|
|Transluminal Biliary Biopsy Forceps Set||BBFS||All lots|
|White Lumax® Guiding Coaxial Catheter||LMGRF-7.0C-80-MPA-PULM||All lots|
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
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)
U.S. Food and Drug Administration
Information for Canadian customers
For information regarding this recall, please see the attached letter in English and French.