Recall Z-1815-2008
Ev3, Inc · initiated April 2, 2008
Product
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.
Codes / lots: Lot No: 4401432
Reason for recall
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).
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1815-2008
- Initiated
- April 2, 2008
- Posted by FDA
- September 11, 2008
- Terminated
- December 10, 2011
- Product code
- NIP – Stent, Superficial Femoral Artery
- Quantity
- 3
- Distribution
- Nationwide Distribution including states of CA and MO.
- Recalling firm
- Ev3, Inc, Plymouth, MN