BLOOMINGTON, Ind.--(BUSINESS WIRE)--On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon® Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date.
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.
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 Cook as soon as possible for credit.
Catheters with Beacon Tip technology are intended for use by physicians who are trained and experienced in each of the procedures for which these devices are indicated for use.
|Product Family||Intended Use|
|Beacon® Tip Torcon NB® Advantage Catheter||The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.|
Beacon® Tip Royal Flush® Plus High-Flow
Beacon® Tip Centimeter Sizing Catheter
Beacon® Tip White Vessel Sizing Catheter
Beacon® Tip Vessel Sizing Catheter
|The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.|
Shuttle® Select Slip-Cath
Slip-Cath® Beacon® Tip Catheter
|The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.|
|FluoroSet® Radiographic Tubal Assessment Set||Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.|
|Haskal Transjugular Intrahepatic Portal Access Set||Intended for transjugular liver access in diagnostic and interventional procedures.|
|Kumpe Access Catheter||Used in combination with a HiWire®, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment.|
|Liver Access and Biopsy Needle Set||Intended for use in obtaining liver histology samples via a jugular vein approach.|
Neff D’Agostino Percutaneous Access Set
Aprima™ Access Nonvascular Introducer Set
|Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures.|
|Selective Salpingography Catheter with Beacon® Tip||Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.|
|Transluminal Biliary Biopsy Forceps Set||Intended for access to and biopsy of tissue within the biliary ductal system.|
|White Lumax® Guiding Coaxial Catheter||Intended for the delivery of angioplasty balloons and other types of interventional devices.|
This recall includes all lots of catheters with the Beacon® Tip technology. A full product listing is attached. Products can be identified by the part number on the outer package of the product label. Products in this recall were distributed globally.
Cook Medical identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. The preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. Cook Medical recognizes that there may be other undetermined contributors to this issue and will continue to investigate.
The FDA and other regulatory agencies around the world have been notified of this action.
Consumers with medical questions or concerns should 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. For information regarding the recall, please contact Stericycle Expert Solutions at 1-866-201-9067.
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 at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at 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 preaddressed form, or submit by fax to 1-800-FDA-0178.
Adverse events may also be reported to 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.