Recall Z-1527-2020 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
| Date | Mar 9, 2020 (initiated Feb 14, 2020) |
| Status | Terminated |
| Reason | Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue. |
| Root cause | Process change control |
| Action | On 02/14/20, Medtronic mailed Urgent Medical Device Recall notices to Healthcare Professionals and Risk Managers. They were advised of the following: 1) Do not use any affected product. Remove and quarantine all unused affected products in your inventory. 2) Return the affected products. Medtronic representatives can assist with facilitating the return of affected product and with identifying suitable replacement product. 3) Complete and return the Customer Confirmation Form. In addition, customers were asked to share the communication within their organization, with other organizations wher |
| Quantity | 1050 |
| Distribution | Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Nor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.