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:
Number of Affected Lots
Pipeline embolization device
Alligator retrieval device
X-Celerator hydrophilic guidewires
UltraFlow HPC flow directed micro catheters/Marathon flow directed micro catheters
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