Recall Z-2045-2013 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics Inc, Dba Ev3 Neurovascular
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.
| Date | Aug 23, 2013 (initiated Jul 19, 2013) |
| Status | Terminated |
| 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 " |
| Root cause | Employee error |
| Action | Covidien sent an Customer Notification letter dated July 19, 2013, to all affected customers who received affected lots of Pipeline Embolization Device (PED). The customer notification letter informed the customers of the problems identified and the actions to be taken. Customer are instructed to reply and fax response form to Covidien Customer Service at (763) 398-7001. Customers are instructed that Customer Service will issue an RGA number for the return of the affected product back to Covidien. Customers are also instructed that upon receipt of a Returned Goods Authorization (RGA) nu |
| Quantity | 62 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.