SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
FDA Recall Z-1213-2012 · Posted 2012-03-15
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Recalling FirmIdev Technologies, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2012-01-31
Date Terminated2013-09-09
Product QuantitySeven devices
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).
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, 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.
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