FDA Medical Device Recalls (openFDA)
ev3, Inc.: Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
- Recall number
- Z-0863-03
- Recalling firm
- ev3, Inc.
- Product
- Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
- Status
- Terminated
- Initiated
- 2003-04-15
- Posted
- 2003-05-22
- Terminated
- 2004-07-02
- Reason
- The label had an expiration date of August 2005, but the correct expiration date was February 2005.
- Root cause
- Other
- Action
- A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.
- Quantity
- 15 units
- Distribution
- Nationwide in United States.
- Lot, serial or model codes
- Lot Number 132612
- 510(k) numbers
- ["K023243"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2183870
- Firm city
- St. Paul
- 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