UPDATED: Cook Medical Expands Recall of Faulty Catheters

UPDATED: Cook Medical Expands Recall of Faulty Catheters
Image: NCCC
October 12, 2015

Cook Medical is announcing a voluntary recall for a specific lot of defective medical equipment.

Last month, the medical manufacturer made the decision to recall Beacon Tip Angiographic Catheters. The items have been found to exhibit tip splitting and separation. The company has received 26 complaints in regards to the defect.

Tip splitting can lead to a loss of device functionality, while separation can have more serious consequences. This event can require medical attention to remove the separated segment or may block blood flow to organs.

Over 2,200 lots and over 95,000 devices are subject to the recall. The affected catheters were distributed between June 2013 and June 2015. Product can be identified by the part number and lot number provided on the outer package product label. The lot numbers for products that are subject to this recall can be found here.

Cook has notified customers and distributors of the recall, requesting that the inventory be quarantined and its use be discontinued. Customers can return the product to the company for credit.

Consumers with questions can contact the company at (800) 457-4500 or (812) 339-2235.

Update: Cook Medical has expanded the recall for Beacon Tip Angiographic Catheters. The tip splitting and separation has resulted in 42 Medical Device Reports disclosed to the Food and Drug Administration (FDA). The affected catheters were distributed globally between September 2012 and September 2015. For a list of the specific models subject to recall, see the FDA release. The product can be identified by the part number provided on the outer package product label.