FDA Medical Device Recalls (openFDA)
Ev3, Inc: ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
- Recall number
- Z-1816-2008
- Recalling firm
- Ev3, Inc
- Product
- ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
- Status
- Terminated
- Initiated
- 2008-04-09
- Posted
- 2008-09-21
- Terminated
- 2009-05-27
- Reason
- An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
- 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
- 1
- Distribution
- CA
- Lot, serial or model codes
- Lot 4401214
- 510(k) numbers
- not on file
- PMA numbers
- ["P000033"]
- Product code
- NIP
- Firm FEI
- 2183870
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28