IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
FDA Recall Z-1550-2013 · Posted 2013-06-18
Recalling FirmIDEV Technologies, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2012-05-29
Date Terminated2013-07-29
Product Quantity3
Reason for Recall
There was an error on the outer labeling of this device. The inner label was correct.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution to the states of FL, NY, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.