In order to diagnose certain medical conditions, medical providers often use angiography. With the aid of catheters, this procedure is performed in one of three ways: MRI, CT scan or X-rays. When a catheter is used, it is inserted through the skin and into an artery. While this may seem like a routine procedure, there have been instances of the catheter tips splitting or breaking, which can cause serious medical issues. The Food and Drug Administration (FDA) announced the recall of the affected Angiographic Catheter tips manufactured by Cook Medical.
Nearly 39,000 Beacon Tip Angiographic Catheters, from more than 2,000 lots, were recalled. The recalled Cook Medical products include: Cook Medical, the tip Slip-Cath® Beacon® Tip Catheters, Torcon NB® Advantage Beacon® Tip Catheters and Royal Flush® Plus Beacon® Tip High-Flow Catheters. The manufacturer initiated the recall on July 2, 2015 after receiving 26 adverse event reports of catheters breaking or splitting. There have also been 14 Medical Device Reports regarding the defective catheter tips. The specific adverse events were not disclosed. Worldwide, more than 95,000 units may be recalled.
Catheter angiography is used to examine blood vessels throughout the body, including in the heart, brain, abdomen, chest, neck, arms and legs. A broken or split catheter could cause injury to any of these body parts or organs. Not only would a broken or split catheter fail to properly function, but the tip could puncture an organ, or block blood flow to organs. Such injuries, could require surgery, result in serious injury or even death.
This recall affects hundreds of catheter lots. Distributors and medical providers can determine if their catheter inventories are subject to the recall, by searching for a specific lot number on the FDA’s website. The recalled catheters were distributed between June 2013 and June 2015, but were manufactured between 2013 and 2014.
Affected persons have been notified of the recall. Letters announcing the recall were mailed to distributors and customers. All agencies that regulate medical equipment, including the FDA, have been informed of the recall. Medical facilities should discontinue use of any recalled catheters, and return them to the manufacturer for a credit.
Patients who have suffered adverse events caused by the defective catheter tips should notify their medical provider, as well as the FDA, so that all adverse events are properly reported.
If you or a loved one suffered a catheter injury during an angiographic procedure, call Nadrich & Cohen, LLP now for a free, confidential consultation.