Z-1550-2013Class II

IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System...

Name: Z-1550-2013 IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System...
Creator: IDEV Technologies, Inc.
Published: 2012-05-29
License: https://open.fda.gov/license/

Idev Technologies, Inc. / initiated 2012-05-29 / Terminated / root cause: labeling and UDI

FDA source

IDEV Technologies, Inc. began a recall of IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures... on 2012-05-29. FDA classified it as Class II and gives the reason as "There was an error on the outer labeling of this device. The inner label was correct". 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-1550-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2013-06-18
Terminated: 2013-07-29
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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: There was an error on the outer labeling of this device. The inner label was correct.
Root cause tag: labeling and UDI
FDA 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 in commerce: 3
Distribution: Nationwide Distribution to the states of FL, NY, and PA.
Product codes and lots: Model Number: S-05-100-120-G3; Lot Number 01049037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1550-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1550-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-18

Product code FGE

K111766Class IISupera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. / cleared 2011-10-19

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)