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COMPANY ANNOUNCEMENT

Cook Medical Issues Global, Voluntary Recall of Catheters with Beacon Tip Technology

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Cook Medical Issues Global, Voluntary Recall of Catheters with Beacon Tip Technology

Summary

Company Announcement Date:
May 03, 2016
FDA Publish Date:
February 09, 2019
Reason for Announcement:
Company Name:
Cook Medical
Brand Name:
Brand Name(s)
Beacon, Shuttle, Fluoro-Set, and others
Product Description:
Product Description
Catheters with Beacon Tip technology

Company Announcement

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 FamilyIntended Use
Beacon® Tip Torcon NB® Advantage CatheterThe 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 Catheter
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 SetUsed 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 SetIntended for transjugular liver access in diagnostic and interventional procedures.
Kumpe Access CatheterUsed 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 SetIntended 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® TipUsed for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Transluminal Biliary Biopsy Forceps SetIntended for access to and biopsy of tissue within the biliary ductal system.
White Lumax® Guiding Coaxial CatheterIntended 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.

List of affected Catheters with Beacon Tip Technology

 

  • Catheter with Beacon Tip technology

Consumers

Cook Medical Customer Relations
1-800-457-4500 or 1-812-339-2235

Media

Marsha Lovejoy
Global Manager, Corporate Content Strategy
marsha.lovejoy@cookmedical.com
1-812-339-2235 ext. 2750