LAP-BAND C-2360Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10811955020305), received between Jun 5, 2018 and Mar 21, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A LEAK IN THE GASTRIC BAND SYSTEM. THE PATIENT HAD THEIR GASTRIC BAND PORT REPLACED ON (B)(6) 2022. REPORT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM UNDER MDR REPORT #: MW5106845.

  Patient problems: Insufficient Information

  MAUDE report 13841036 ↗
• InjuryMar 13, 2019Migration; Migration

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT REVISION SURGERY DUE TO PORT DISPLACEMENT AND INFECTION." IT WAS NOTED THE DEVICE HAD "TO BE REPOSITIONED SINCE IT HAD FLIPPED. THERE HAS BEEN PERSISTENT DRAINAGE FROM THE WOUND SINCE THEN. ANTIBIOTICS WERE GIVEN AND THE SINUS ACTUALLY CLOSED A COUPLE OF TIMES BUT REOPENED. THERE HAS NEVER BEEN CELLULITIS OR PURULENT DRAINAGE, ALWAYS JUST SEROUS FLUID IN VERY SMALL AMOUNTS. HAS BEEN ON TOPICAL AND ORAL ANTIBIOTICS ALMOST CONTINUOUSLY."

  Patient problems: Unspecified Infection

  MAUDE report 8418890 ↗
• MalfunctionJun 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT THAT WE RECENTLY REVISED. WHEN WE GOT IN THERE TO THE PORT THE PIECES HAD BASICALLY FALLEN APART." THE PATIENT HAD AN ABRUBT STOP IN TIGHTNESS OF THE BAND.

  Patient problems: Failure of Implant

  MAUDE report 7575889 ↗
• MalfunctionJun 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT THAT WE RECENTLY REVISED. WHEN WE GOT IN THERE TO THE PORT THE PIECES HAD BASICALLY FALLEN APART." THE PATIENT HAD AN ABRUBT STOP IN TIGHTNESS OF THE BAND.

  Patient problems: Failure of Implant

  MAUDE report 7570410 ↗