ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before
FDA device recall Z-1816-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NIP
- Quantity affected
- 1
- Distribution
- CA
- Date initiated
- 2008-04-09
- Date posted
- 2008-09-21
- Date terminated
- 2009-05-27
- Location
- Plymouth, MN
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