RecallRadar

FDA Device recall Z-1550-2013

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

On 2013-06-26 the FDA classified a Class II recall of IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System by Idev Technologies, citing there was an error on the outer labeling of this device. The inner label was correct.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1550-2013
ClassificationClass II
Statusterminated
Initiated2012-05-29
Published2013-06-26
Last updated2026-09-13 11:53 UTC
CompanyIdev Technologies
DistributionUS

Product

IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms

Reason

There was an error on the outer labeling of this device. The inner label was correct.

Identifiers

code_infoModel Number: S-05-100-120-G3; Lot Number 01049037

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1550-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.