The new recall involves 84,278 devices that have PTFE coatings.
|Surface Solutions Group, which has been raising the alarm about PTFE coating problems in recent years, previously provided Qmed with this photo of wires with flaking PTFE coatings.|
Medtronic announced Friday that its is engaging in a recall involving a host of products with polytetrafluoroethylene (PTFE) coatings that could separate from delivery wire or stylets.
PTFE particles that enter the bloodstream pose the danger of thromboembolic events that in turn pose the risk for an extremely dangerous pulmonary embolism or stroke.
The recall, which Medtronic began October 5 via letter to customers, involves 84,278 units of products including the Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire, as well as the stylet containing UltraFlow flow directed microcatheters and Marathon flow directed microcatheters.
Medtronic is asking customers to return all affected products and has notified FDA and other regulatory agencies of the problem.
|Discover more about connected medical device innovations at BIOMEDevice San Jose, December 7-8, 2016.|
Products were manufactured between July 2014 and September 2016. Additional information and specific lot numbers are available on Medtronic's website.
The medical device industry has already been aware of problems with flaking polytetrafluoroethylene (PTFE) coatings since the EPA required a reformulation to remove the suspected carcinogen perfluorooctanoic acid (PFOA). FDA last year warned health providers of serious adverse events related both the hydrophilic and hydrophobic coatings used on guidewires and a host of other intravascular procedure devices.
Back in 2014, before it became part of Medtronic, Covidien issued a voluntary recall of 650 of its Pipeline embolization devices and Alligator retrieval devices after internal testing revealed coating delamination.
The new recall appears to be much wider in scope and covering a host of devices:
- The Pipeline embolization device is for treatment of giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.; the first generation of the devices had a PTFE coated delivery wire as part of the disposable delivery system. (The second-generation Pipeline Flex is not affected by this recall.)
- The Alligator retrieval device is used for foreign body retrieval in the peripheral and neuro-vasculature.
- The X-Celerator hydrophilic guidewire is for selective placement of catheters in the peripheral, visceral, and cerebral vasculature.
- The UltraFlow flow directed micro catheter provides subselective infusion of physician-specified therapeutic agents in tortuous, distal vessels, while the Marathon is for infusion of physician-specified therapeutic agents in the peripheral and neurovasculature.
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