Medtronic Announces Voluntary Recall of Certain Neurovascular Devices

October 18, 2016—Medtronic plc announced 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 microcatheters and Marathon flow-directed microcatheters. 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.

According to Medtronic, this voluntary recall is being conducted because of the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. If the coating separates 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, advised the company.

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

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 online 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 recall effects 1,742 lots of the Pipeline embolization device, 171 lots of the Alligator retrieval device, 210 lots of the X-Celerator hydrophilic guidewires, and 1,790 lots of the UltraFlow HPC and Marathon flow-directed microcatheters.

The company noted that it is the first-generation of the Pipeline device that is affected by this action because of the PTFE-coated delivery wire, which is part of the disposable delivery system. The braid implant is not affected. The second-generation Pipeline Flex embolization device is not affected by this recall.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Reports may also be submitted by regular mail or by fax. Forms can be downloaded at www.fda.gov/MedWatch/getforms.htm or requested by calling (800) 332-1088. When completed, reports should be returned to the address on the form or transmitted by fax to (800) FDA-0178.

For information or to report a problem, contact the Medtronic Lifeline Service at any time at (877) 526-7890, advised the company.