News | Angiographic Catheter | October 14, 2015

Cook Medical Expands Global Recall of Select Beacon Tip Angiographic Catheter Sizes

Recall is an expansion of voluntary lot-specific recall issued in July

Cook Medical, expanded recall, October 2015, Beacon Tip Angiographic Catheters

Image courtesy of Cook Medical

October 14, 2015 — On Oct. 7, 2015, Cook Medical initiated a voluntary recall for select sizes of Beacon Tip Angiographic Catheters. This recall includes all lots of these select sizes of the Beacon Tip Angiographic Catheters. This recall is an expansion of the voluntary lot-specific recall issued on July 2, 2015. The products include specific versions of the Torcon NB Advantage Beacon Tip Catheters (catalog prefix HNBR4.0, HNBR4.1 and only HNBR5.0 with the RUC suffix), Royal Flush Plus Beacon Tip High-Flow Catheters (catalog prefix HNR4.0), and Slip-Cath Beacon Tip Hydrophilic Catheters (catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with the RUC suffix), and Shuttle Select Slip-Cath catheters (catalog prefix SCBR4.5).

The list of lot numbers affected by the recall can be found here.

The catheters have been found to exhibit tip splitting or separation, which has resulted in 42 Medical Device Reports. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or, if not retrieved, has the potential to occlude blood flow to end organs.

The Beacon Tip Angiographic Catheters in this recall were distributed globally between September 2012 and September 2015. Product can be identified by the part number provided on the outer package product label. The part numbers for products subject to this recall are those with catalog number prefixes and suffixes listed in the initial paragraph above. All lots currently in distribution are affected.

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.

The U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world have been notified of this action.

Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339- 2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at [email protected]

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

For more information: www.cookmedical.com

Related Content

Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
Overlay Init