Recall Z-1453-2014 ยท DQY Catheter, Percutaneous
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
| Date | Apr 16, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. |
| Root cause | Process change control |
| Action | A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain |
| Quantity | 32 units total (23 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.