FDA Medical Device Recalls (openFDA)
ev3, Inc.: ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMB 4-7-21-80
- Recall number
- Z-0606-04
- Recalling firm
- ev3, Inc.
- Product
- ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMB 4-7-21-80
- Status
- Terminated
- Initiated
- 2004-01-29
- Posted
- 2004-07-20
- Terminated
- 2005-11-08
- Reason
- After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Root cause
- Other
- Action
- A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.
- Quantity
- 446
- Distribution
- The product was distributed nationwide in the United States and internationally to China and Ireland.
- Lot, serial or model codes
- Lots 262849 through 445216
- 510(k) numbers
- ["K033134"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2183870
- Firm city
- Saint 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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