Recall Z-1816-2008 ยท NIP Stent, Superficial Femoral Artery
Ev3, Inc
ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
| Date | Sep 21, 2008 (initiated Apr 9, 2008) |
| Status | Terminated |
| Reason | An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent. |
| Root cause | Labeling mix-ups |
| Action | ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested. |
| Quantity | 1 |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.