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Cook Medical Cardiac Catheters Recalled Due to Faulty Tips

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Nearly 39,000 Cook Medical Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters have been recalled because their tips may split or separate from the catheter, causing injury or even death.

The Food and Drug Administration (FDA) has classified this a Class 1 recall—the most serious recall category—for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram. If the tip separates from the catheter, it could enter the patient’s bloodstream and cause serious injury or even death. An intervention may be needed to retrieve the tip, and tip splitting or separation may cause the device to stop working, interfering with the imaging procedure. Cook Medical says it has received 26 reports of the device malfunctioning. Fourteen of these malfunctions resulted in reports of injuries.

The catheter is inserted into the body through a small puncture in the skin and it is placed into the blood vessel along a guide wire before contrast dye is injected. During the angiogram, an X-ray machine takes a series of images (angiograms) that give the physician a detailed look at the heart’s blood vessels. The doctor can also perform procedures such as an angioplasty during the coronary angiogram, the Mayo Clinic explains. While major complications are rare, the Mayo Clinic says there is a risk of heart attack, stroke, injury to the artery, allergic reaction to the dye or medications, excessive bleeding, and infection.

According to the recall notice, the affected Cook Medical catheters were manufactured between May 9, 2013 and September 1, 2014, and were distributed from June 6, 2013 to June 25, 2015, according to the FDA. The recall included 38,895 catheters in the United States. A complete list of affected lot numbers can be found on the Food and Drug Administration (FDA) web site.

Cook Medical sent customers an Urgent Medical Device Recall letter on July 2, instructing them to immediately quarantine the recalled catheters and return them to Cook Medical as soon as possible. Customers can contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235, Monday through Friday from 7:30 a.m. to 5:00 p.m., EST.

Cook Medical asks customers to report any adverse events to the company at 800-457-4500 or 812-339-2235, Monday through Friday from 7:30 a.m. to 5:00 p.m., Eastern Time or by email to CustomerRelationsNA@cookmedical.com. The FDA also asks health care professionals and patients to report adverse events or side effects related to the use of these catheters through the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/medwatch/report.htm.

 

 

breakinglawsuitnews.com disclaimer: This article: Cook Medical Cardiac Catheters Recalled Due to Faulty Tips was posted on Monday, August 17th, 2015 at 6:00 am at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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