FDA Recall
Terminated
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.
Recall: Z-1815-2008
·
Initiated April 2, 2008
Recall
- Recall Number
- Z-1815-2008
- Event Number
- 48098
- FEI Number
- 2183870
- Product Code
- NIP
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 2, 2008
- Posted
- September 11, 2008
- Terminated
- December 10, 2011
- Address
- Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890
Description
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.
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).
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.
Distribution
Nationwide Distribution including states of CA and MO.
Quantity
3