News | Cath Lab | October 18, 2016

Medtronic Announces Voluntary Recall of Pipeline Embolization Device, Four Other Products

Company warns that polytetrafluoroethylene (PTFE) coating may separate and detach from Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, Ultraflow and Marathon Flow directed micro catheters

recall, alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow flow directed micro catheters, Marathon flow directed micro catheters

October 18, 2016 — Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.

Medtronic initiated customer communication of the recall by letter on Oct. 5, 2016, and is requesting customers to quarantine all affected product that remain in the inventory and return to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

At the initiation of this recall, 84,278 units potentially affected by this recall had been distributed worldwide. The products were manufactured from July 2014 to September 2016. Additional information about the recall, including the specific lot numbers of affected product, can be found at http://bit.ly/2dTvety.

Medtronic is taking this voluntary action as a precaution and has received no reports of patient injuries to date related to this issue. The full recalled product list of affected lot totals is itemized below:

Product Name
Number of Affected Lots

Pipeline embolization device
1,742

Alligator retrieval device
171

X-Celerator hydrophilic guidewires
210

UltraFlow HPC flow directed micro catheters/Marathon flow directed micro catheters

1,790

 

 

 

 

 

 

 

 

The Pipeline embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The first-generation Pipeline embolization device is affected by this action due to the PTFE-coated delivery wire, which is part of the disposable delivery system (the braid implant is not affected). The second-generation device, Pipeline Flex embolization device, is not affected by this recall.

The Alligator retrieval device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval. The X-Celerator hydrophilic guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures. The UltraFlow flow directed micro catheter is designed for the subselective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The Marathon Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast.

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

For more information: www.fda.gov

Related Content

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...
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
Overlay Init