News | Angiographic Catheter | August 11, 2015

Cook Medical Issues Global Recall of Beacon Tip Angiographic Catheter Products

Company has received reports of catheter tip splitting or separating from the catheter, possibly ending up in the bloodstream

Cook Medical, global recall, beacon tip angiographic catheters, FDA

August 11, 2015 — Cook Medical initiated a voluntary recall July 2 of 2,239 lots of beacon tip angiographic catheters. A total of 95,167 devices globally are subject to this recall. The products include specific versions and lot numbers of the Torcon NB Advantage beacon tip catheters, Royal Flush Plus beacon tip high-flow catheters and Slip-Cath beacon tip catheters.

Beacon tip angiographic catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram used to diagnose heart conditions. Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.

The catheters in this recall 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 subject to the recall can be found at the following link: http://mms.businesswire.com/...

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 the company as soon as possible for credit.

Adverse events or quality problems experienced with use of the product may also be reported to the U.S. Food and Drug Administration (FDA).

For more information: www.fda.gov/medwatch

Related Content

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.