Class I Recall of Medtronic Recalls Neurovascular Products

PUBLISHED: Dec 1, 2016
Source: Food and Drug Administration

Medtronic is recalling certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters. See the recall notice, link below, for specific lot numbers.

The recall is issued due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. If the PTFE separates from the device, it could enter the blood stream of the patient. PTFE particles in the blood stream may lead to downstream blood clots and/or irreversible brain injuries including ischemic stroke, thrombosis, and hemorrhage.

The use of affected product may cause serious adverse health consequences, including death.

On October 5, 2016 Medtronic sent an Urgent Medical Device Recall Notice to all affected customers. The notice asked customers to:

  • Remove and quarantine all unused affected products.
  • Return the affected products to Medtronic. Customers are instructed to work with their Medtronic representative to assist in the return of the product, and assist with identifying a replacement product.
  • Complete and return the Customer Confirmation Certificate via fax at 1-949-434-5020 to the attention of Neurovascular Quality

Please see the Recall Notice for additional information.

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