Z-1816-2008
ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214...
Medtronic, Inc. / initiated 2008-04-09 / Terminated / root cause: labeling and UDI
Ev3, Inc began a recall of ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07 on . The reason FDA records is "An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1816-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
- Product code
- NIP Stent, Superficial Femoral Artery
- Reason for recall
- An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
- Root cause tag
- labeling and UDI
- FDA 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 in commerce
- 1
- Distribution
- CA
- Product codes and lots
- Lot 4401214
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