Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Pipeline Embolization Device (PED). Used endovascular treatment of adults with Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to Potential for the PTFE (polytetrafluoroethylene) coating to delaminate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Micro Therapeutics Inc, Dba Ev3 Neurovascular directly.
Affected Products
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Quantity: 32 units total (23 units in US)
Why Was This Recalled?
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Micro Therapeutics Inc, Dba Ev3 Neurovascular
Micro Therapeutics Inc, Dba Ev3 Neurovascular has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report