Over 4M Beacon Tip Catheters Recalled for Polymer Degradation

Megan Brooks

May 04, 2016

Cook Medical has voluntarily recalled 4,146,309 catheters with Beacon Tip technology because of reports of polymer degradation of the catheter tip, according to a company news release posted May 3 on the US Food and Drug Administration (FDA) website.

This recall includes all lots of catheters with the Beacon Tip technology. The company has provided a complete list of the recalled catheters and their intended uses, and a separate list with product numbers by catheter type. The catheters, which were distributed globally, can be identified by the part number on the outer package of the product label.

Beacon Tip catheters are used in several different procedures, including but not limited to the peripheral and coronary vascular system and genitourinary system.

The company says the recall stems from an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. To date, they have received 30 medical device reports.

"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," the company notes in the release.

"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," they say.

Cook Medical has notified its customers and distributors by recall notification letters. The letters ask customers and distributors to quarantine and discontinue use of all potentially affected catheters and return them to Cook Medical for credit.

Consumers with medical questions or concerns may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 am and 5 pm ET. For more information regarding the recall, contact Stericycle Expert Solutions at 1-866-201-9067.

Adverse reactions or quality problems with these products may be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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