Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Includes:

• Pipeline Embolization Device
• Alligator Retrieval Device
• X-Celerator Hydrophilic Guidewire
• Ultraflow and Marathon Flow Directed Micro Catheters

[Posted 10/18/2016]

AUDIENCE: Risk Manager, Neurology

ISSUE: Medtronic 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 micro catheters and Marathon flow directed micro catheters.

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.

BACKGROUND: 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.

RECOMMENDATION: Medtronic notified customers by letter on October 5, 2016, and is requesting customers quarantine all affected product that remain in inventory and return to Medtronic.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/18/2016 -Press Release - Medtronic]