Recall Z-1815-2008 ยท NIP Stent, Superficial Femoral Artery
Ev3, Inc
ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.
| Date | Sep 11, 2008 (initiated Apr 2, 2008) |
| Status | Terminated |
| Reason | Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135). |
| Root cause | Employee error |
| Action | ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product. |
| Quantity | 3 |
| Distribution | Nationwide Distribution including states of CA and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.