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Medtronic Recalls Pipeline Embolization Device

October 18, 2016 — Medtronic has recalled four devices that treat brain aneurysms due to ongoing problems with the plastic coating detaching, which could potentially cause a deadly stroke.

There have been no reports of patient injuries and the recall was issued as a precaution, according to a statement from Medtronic.

The recall does not include the second-generation device, Pipeline™ Flex. However, it does include the following products:

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

The problem is that the plastic coating on the devices can separate from the delivery wire. The coating could block blood vessels in the brain and cause a stroke or death.

The coating is made from polytetrafluoroethylene (PTFE) and it is designed to reduce friction between the devices and the guidewire.

Metronic apparently has not fixed problems discovered years ago. In April 2014, another recall was issued for some Pipeline and Alligator devices because the PTFE coating could detach.

The recall involves about 84,278 individual devices that were manufactured between July 2014 and July 2016. For a complete list of specific lot numbers, click here (PDF).

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