Recall Z-2045-2013— Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class II · Terminated
Class II FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2013-07-19, terminated 2013-10-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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 ".
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-19
- Terminated
- 2013-10-17
- Firm location
- Irvine, CA, United States
Product description
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.
Reason for recall
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 "
Data sourced from openFDA. This site is unofficial and independent of the FDA.