Recall Z-1701-2018 ยท NRY Catheter, Thrombus Retriever
Micro Therapeutics Inc, Dba Ev3 Neurovascular
MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
| Date | May 16, 2018 (initiated Feb 26, 2018) |
| Status | Terminated |
| Reason | There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire. |
| Root cause | Process design |
| Action | The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality. |
| Quantity | 1,942 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141516 | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Feb 5, 2015 |