The LAP-BAND Adjustable Gastric Banding System with the Access Port II B-2215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811955020152), received between Oct 22, 2015 and Oct 22, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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.

• MalfunctionOct 22, 2015Leak/Splash

  REPORTED AS: THE PATIENT WAS EXPERIENCING AN INCREASE IN APPETITE, DECREASED SATIETY, AND INCREASING WEIGHT GAIN. THE PHYSICIAN CHECKED THE LAP-BAND AND FOUND 1CC OF FLUID, MUCH LESS FLUID THAN EXPECTED. THE PHYSICIAN ADDED 3CC AND ASPIRATED BUBBLES; NO FLUID WAS RETURNED. THE PHYSICIAN CONFIRMED A PORT LEAK. THE PORT WAS REMOVED AND REPLACED. FOLLOW-UP FOUND THAT THE OPERATIVE REPORT INDICATED A "HOLE IN THE TUBING PORTION OF THE PORT" AND A "PREVIOUS TRANSVERSE SCAR WAS NOTED IN THE UPPER ABDOMEN WITH THE PORT PALPABLE UNDERNEATH."

  Patient problems: Weight Changes

  MAUDE report 5167592 ↗