FDA Medical Device Recalls (openFDA)
Medtronic CardioVascular: Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.
- Recall number
- Z-0655-2010
- Recalling firm
- Medtronic CardioVascular
- Product
- Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.
- Status
- Terminated
- Initiated
- 2009-07-17
- Posted
- 2010-01-19
- Terminated
- 2010-06-21
- Reason
- Mislabeling-- A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
- Root cause
- Labeling mix-ups
- Action
- Medtronic, Inc. issued an "Urgent - Voluntary Medical Device Recall" communication dated July 17, 2009 asking consignees to segregate labeled lot numbers until a representative from the firm arrived to retrieve the products. For further information, contact your local Medtronic representative or call Medtronic, Inc. at 1-707-525-0111.
- Quantity
- 20 units
- Distribution
- Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
- Lot, serial or model codes
- Lot Number: 0000983806, use by date 03/17/2011.
- 510(k) numbers
- ["K062264"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3001452571
- Firm city
- Santa Rosa
- Firm state
- CA
- 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