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Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of ad
Recalled September 4, 2013 · FDA recall Z-2045-2013 · Micro Therapeutics Inc,
Hazard
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 " · FDA Class II
Units
62 units
Sold at
US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
Description
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 "
Product
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.
Manufacturer(s)
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →