FDA Medical Device Recalls (openFDA)
IDEV Technologies, Inc.: IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
- Recall number
- Z-1550-2013
- Recalling firm
- IDEV Technologies, Inc.
- Product
- IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
- Status
- Terminated
- Initiated
- 2012-05-29
- Posted
- 2013-06-18
- Terminated
- 2013-07-29
- Reason
- There was an error on the outer labeling of this device. The inner label was correct.
- Root cause
- Labeling mix-ups
- Action
- The firm decided to rework the products that were in their control at the time and the one that was not in their control was corrected by an IDEV employee. That hospital was called and notified of the situation in May 2012.
- Quantity
- 3
- Distribution
- Nationwide Distribution to the states of FL, NY, and PA.
- Lot, serial or model codes
- Model Number: S-05-100-120-G3; Lot Number 01049037
- 510(k) numbers
- ["K111766"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3005325609
- Firm city
- Webster
- Firm state
- TX
- 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