Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to Covidien Neurovascular has initiated the recall of several...
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) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Quantity: 62 units
Why Was This Recalled?
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
Where Was This Sold?
This product was distributed to 19 states: AZ, CA, CO, FL, GA, IL, IA, KY, MA, MO, NV, NY, NC, OR, TN, TX, UT, VA, WI
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