Flexxus® Endoscopic Biliary Stent LXB08100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741099267), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K031186); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2019Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE UNIT OF GRADIENT MAGNETIC FIELD ON THE PACKAGING INSERT WAS ALLEGEDLY INCORRECT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8229606 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031186. One submission often covers many models, so check the product and lot details in each record.

• Z-0729-2007 · Mar 14, 2007 · Terminated
  Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
• Z-0730-2007 · Mar 14, 2007 · Terminated
  Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060
• Z-1577-05 · Jul 28, 2005 · Terminated
  Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060