Class 1 Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

 

 

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

 

Recalled Products:

  • Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Micro Catheter, and X-Celerator Hydrophilic Exchange Guidewire
  • Lot Numbers: See full list of lot numbers
  • Distribution Dates: November 10, 2014 to August, 5, 2015
  • Manufacturing Dates: July 2014 to September 2016
  • Devices Recalled in the U.S.

Device Use

The following devices are designed to be used together for treatment of cerebral aneurysms. An aneurysm is a localized, blood-filled ballooning in the wall of a blood vessel.

 

The Pipeline™ Embolization Device (PED) is a wire mesh cylindrical implanted device, composed of braided platinum and nickel-cobalt chromium alloy, which is placed within an artery in the brain. The PED is intended to treat adults with large or giant, wide-necked brain aneurysms of the major artery supplying the front of the brain called the internal carotid artery.

The Alligator™ Retrieval device contains micro forceps and is intended for retrieval of foreign bodies within the blood vessels of the brain.

The X-Celerator™ Hydrophilic Guidewire is used to aid in the placement of catheters in the brain during endovascular procedures.

The UltraFlow™ and Marathon™ Flow Directed Micro Catheters are designed for the infusion of physician-specified therapeutic agents such as embolization materials.

Reason for Recall

Medtronic is recalling of certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters. They are issuing this recall 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.

Who May be Affected

  • Health care providers using these neurovascular devices
  • All patient groups undergoing procedures involving these neurovascular devices

What to Do

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.

Date Recall Initiated:

October 5, 2016

 

 

 

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