Z-1213-2012

SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for...

Name: Z-1213-2012 SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for...
Creator: Idev Technologies, Inc.
Published: 2012-01-31
License: https://open.fda.gov/license/

Idev Technologies, Inc. / initiated 2012-01-31 / Terminated / root cause: labeling and UDI

FDA source

Idev Technologies, Inc. began a recall of SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced... on 2012-01-31. The reason FDA records is "The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1213-2012
Status: Terminated
Initiated: 2012-01-31
Posted: 2012-03-15
Terminated: 2013-09-09
Recalling firm: Idev Technologies, Inc.
Product: SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: IDEV Technologies sent an "URGENT PRODUCT RECALL" letter dated February 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to sign the letter and return a copy to the firm via fax to 281-525-2001 to indicate that they have received the notification. Contact the firm at 281-525-2052 for questions regarding the notice.
Quantity in commerce: Seven devices
Distribution: Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
Product codes and lots: Device Codes: S-04-120-120-G3 (Lot Number 05180062); S-04-040-120-G3 (Lot Numbers 05180031); S-04-060-120-G3 (Lot Number 05187032); S-05-040-120-G3 (Lot Number 05180034); S-05-060-120-G3 (Lot Number 05180035); S-05-080-120-G3 (Lot Number 05180036); S-05-100-120-G3 (Lot Number 05180037); and S-06-080-120-G3 (Lot Number 05180042).

Product code FGE

K093893Class IISupera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. / cleared 2010-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)