Recall Z-0120-2016 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics Inc, Dba Ev3 Neurovascular
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex
| Date | Oct 14, 2015 (initiated Sep 4, 2015) |
| Status | Terminated |
| Reason | The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use. |
| Root cause | Process control |
| Action | The firm, Medtronic, sent a "Notification of Recall" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken. The firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product. The firm asks customers to take the following steps: 1) Stop using this product immediately. 2) Segregate this product from other Inventory. 3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. |
| Quantity | 23 devices |
| Distribution | US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.