LAP-BAND Calibration Tube A-2017Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811955020022), received between Oct 8, 2015 and Oct 8, 2015 — classified as 1 injury.

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.

• InjuryOct 8, 2015Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE CALIBRATION TUBE WAS BEING USED DURING A SLEEVE GASTRECTOMY. WHILE THE TUBE WAS INFLATED, THE NURSE ANESTHETIST PULLED THE DEVICE TO TAKE IT OUT, AND THIS CAUSED A TEAR IN THE ESOPHAGUS BECAUSE THE BALLOON WAS STILL INFLATED. THE PHYSICIAN REPAIRED THE TEAR BY PLACING A COUPLE OF SUTURES. REPORTER STATED "THIS WAS NOT A PRODUCT PROBLEM, AND TO DATE THERE HAVE BEEN NO BAD OUTCOMES FOR THE PATIENT DUE TO THIS EVENT."

  Patient problems: Perforation of Esophagus

  MAUDE report 5135900 ↗