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 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...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init