LAP-BAND AP Adjustable Gastric Banding System B-2265Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10811955020237), received between Mar 3, 2015 and Dec 14, 2018 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "LEAKY" LAP-BAND. THE BAND WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 8166592 ↗
• MalfunctionOct 26, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. "[PATIENT] HAD NOT BEEN ABLE TO HOLD VOLUME FOR SEVERAL MONTHS. [PATIENT] HAD GAINED WEIGHT. RADIOGRAPHIC STUDIES WITH CONTRAST ARE NEGATIVE FOR BAND OR TUBING LEAK." DEVICE WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 6980611 ↗
• MalfunctionMay 24, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. "SIX YEARS AGO [PATIENT] NOTED LOSS OF SATIETY. EVALUATIONS CONFIRMED TUBING BREAK WHICH WAS REPAIRED IN 2011. VOLUME CHECK OF [PATIENT'S] SYSTEM WAS 0 CC AND REPEATED INJECTIONS MEET NO RESISTANCE AND FAIL TO RETURN ANY VOLUME INDICATING A TUBING BREAK. CONTRAST RADIOLOGY SHOWS A COMPLETE TUBING BREAK ABOUT 6 INCHES FROM THE BAND." PORT AND TUBING REPLACEMENT.

  Patient problems: Failure of Implant

  MAUDE report 6589187 ↗
• MalfunctionSep 22, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT LEAK." THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 5970218 ↗
• MalfunctionAug 16, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "LEAKING PORT." THE DEVICE WAS EXPLANTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5878658 ↗
• MalfunctionApr 29, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: THE PATIENT'S LAP-BAND SYSTEM "WASN'T GETTING RESTRICTION, CAME FOR VOLUME CHECK [THE PATIENT] WAS SUPPOSED TO HAVE 8CC BUT ONLY HAD 4CC." THE PORT WAS REMOVED AND REPLACED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5619536 ↗
• InjuryApr 7, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "HAD ABDOMINAL PAIN, PRESENTED TO HOSPITAL AND FOUND TO HAVE FREE FLUID AND SEPSIS, BAND EXPLANTED. PATIENT PRESENTED TO HOSPITAL AND WAS TAKEN TO THE OPERATING ROOM. PATIENT WANTS THE BAND REPLACED."

  Patient problems: Pain; Sepsis

  MAUDE report 5555132 ↗
• MalfunctionOct 21, 2015Leak/Splash

  REPORTED AS: PATIENT WAS HAVING ADJUSTMENTS PERFORMED, STATED THE LAP-BAND SYSTEM WAS WORKING WELL UNTIL 6 MONTHS AGO WHEN THEY LOST ALL RESTRICTION. PATIENT HAD DIAGNOSTIC TESTING AND THE PHYSICIAN DETERMINED THERE WAS A PORT LEAK AND THE PORT WAS REPLACED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5163747 ↗
• MalfunctionMar 3, 2015Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED EXPLANT AND REPLACEMENT OF ORIGINAL LAP-BAND DEVICE DUE TO LEAK AND EXPLANT AND REPLACEMENT OF SECOND PORT.

  Patient problems: Failure of Implant

  MAUDE report 4580092 ↗