LAP-BAND AP Adjustable Gastric Banding System B-2260Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10811955020220), received between Jan 2, 2014 and Apr 6, 2018 — classified as 9 injuries, 9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2018Device Slipped; Device Slipped

  REPORTED AS: A PATIENT IN THE LAP-BAND APOLLO-001 LBMI CLINICAL STUDY WAS HOSPITALIZED DUE TO "LAP BAND SLIP" AND HAD BAND REOPERATION. DEVICE REMAINS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403655 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT IN THE LAP-BAND HERO CLINICAL STUDY HAD AN ADVERSE EVENT OF "ABDOMINAL PAIN, UNDETERMINED ETIOLOGY". THE PATIENT WAS HOSPITALIZED AND HAD "GALLBLADDER WORKUP, WHICH WAS NORMAL". DEVICE REMAINS IMPLANTED.

  Patient problems: Abdominal Pain

  MAUDE report 7273428 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY HAD AN ADVERSE EVENT OF CHRONICAL ABDOMINAL PAIN AND EMESIS. THE DEVICE WAS EVENTUALLY REMOVED.

  Patient problems: Pain; Vomiting

  MAUDE report 7084207 ↗
• MalfunctionNov 15, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO BE "SEEN FOR A LAPBAND TUBING LEAK. PATIENT HAD A PREVIOUS PORT LEAK WHICH WAS REPAIRED (NEW PORT INSERTED) SEVERAL YEARS AGO WHEN SUDDEN LOSS OF SATIETY WAS NOTED AND WEIGHT REGAIN BEGAN. AFTER THE NEW PORT WAS INSERTED THE [PATIENT] RECEIVED ADJUSTMENTS BUT VOLUME CHECK CONSISTENTLY WAS LESS THAN IT WAS CALCULATED TO BE AND SATIETY AFTER FILLS LASTED ONLY 24 HOURS. VOLUME CHECK OF THE SYSTEM IS <2 CC EVEN A COUPLE OF DAYS AFTER FILLING 6 CC SALINE INDICATING A LEAK. PATIENT WILL HAVE THE ENTIRE LAPBAND REPLACED."

  Patient problems: Failure of Implant

  MAUDE report 7033681 ↗
• MalfunctionOct 26, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. "[PATIENT WAS] SEEN FOR EVALUATION OF LAPBAND INTOLERANCE. [PATIENT] HAD THE BAND PLACED FOR SEVERAL YEARS AGO AND LOST ALMOST (B)(6) . [PATIENT] HAS HAD NUMEROUS ADJUSTMENTS CAN EITHER EAT TOO MUCH OR IS OBSTRUCTED W/ GERD AND DYSPHAGIA TO SOLIDS. LEAK FOUND IN OPERATION." DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Obstruction/Occlusion; Regurgitation

  MAUDE report 6981377 ↗
• MalfunctionAug 10, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. "[PATIENT] HAS LACKED OF SATIETY. INJECTION OF FLUID AND ATTEMPTS OF ASPIRATION THROUGH [PATIENT'S] PORT REVEALED THAT THERE WAS NO FLUID IN SYSTEM, AND INJECTION WAS NOT RETURNED INDICATING A COMPLETE DISRUPTION OF [PATIENT'S] TUBING WHICH IS CONFIRMED RADIO GRAPHICALLY BREAKING THE TUBING AT THE METAL CONNECTOR WITH THE TIP OF THE TUBING BEING IN THE PELVIS. THIS WAS LAPAROSCOPICALLY RETRIEVED." THE DEVICE WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 6785653 ↗
• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT INFECTION, [PATIENT] HAS DRAINAGE AT THE PORT SITE AND THEY WANT TO REMOVE THE PORT, TREAT IT AND GO BACK LATER TO REPLACE." IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 6465495 ↗
• InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY HAD AN ADVERSE EVENT OF DEHYDRATION AND ABDOMINAL PAIN. THE EVENTS WERE REPORTED AS SERIOUS ADVERSE EVENTS. THE PATIENT WAS HOSPITALIZED AND THE EVENTS WERE RESOLVED. DEVICE REMAINS IMPLANTED.

  Patient problems: Dehydration; Pain

  MAUDE report 6222188 ↗
• MalfunctionSep 22, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO DO "WELL BUT THE PATIENT NOTICED A LOSS OF SATIETY AND WEIGHT REGAIN BEGAN. THE PATIENT RECEIVED ADJUSTMENTS BUT VOLUME CHECKS CONSISTENTLY REVEALED LESS VOLUME. SATIETY AFTER FILLS LASTED ONLY 24 AT THE MOST." DEVICE HAS BEEN REMOVED AND PORT REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 5971733 ↗
• MalfunctionMay 27, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO "PORT HAD A LEAK." THE PATIENT HAD THEIR LAP-BAND PORT REMOVED AND REPLACED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5686002 ↗
• MalfunctionApr 20, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: THE PATIENT'S LAP-BAND SYSTEM WAS REPORTED TO HAVE "COME IN FOR A FILL, THEN CAME BACK FOR DECREASED SATIETY AND NO RESTRICTION. PATIENT HAD A VOLUME CHECK, AND LOST VOLUME SO THEY WERE SENT FOR A UPPER GI." THE PORT WAS REMOVED AND REPLACED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5591816 ↗
• InjuryNov 3, 2015Inadequacy of Device Shape and/or Size

  REPORTED AS: THE PATIENT WAS NOT TOLERATING SOLIDS OR LIQUIDS. THE PHYSICIAN PERFORMED AN ADJUSTMENT AND DEFILLED THE LAP-BAND SYSTEM TO 0CC, HOWEVER THE PATIENT SAW NO IMPROVEMENT. THE PATIENT'S LAP-BAND WAS EXPLANTED AND REPLACED WITH A LARGER SIZED LAP-BAND.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5198957 ↗
• MalfunctionOct 16, 2015Leak/Splash

  REPORTED AS: PHYSICIAN SUSPECTED A LEAK IN THE LAP-BAND SYSTEM DUE TO INITIAL CHANGE IN RESTRICTION. RESTRICTION WOULD DIMINISH IN 1-2 DAYS. FILL VOLUME WAS ASSESSED, WITH SERIAL VOLUME MEASUREMENTS INDICATING VOLUME LOSS. THE LAP-BAND PORT WAS EXPLANTED AND REPLACED, AND THE SURGEON NOTED A LEAK FROM THE POSTERIOR SEAL OF THE PORT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5157192 ↗
• MalfunctionOct 15, 2015Leak/Splash

  THE PATIENT REPORTED THEY HAD A PORT REPLACEMENT OF THEIR LAP-BAND SYSTEM. SOMETIME AFTER IMPLANTATION, THE PATIENT EXPERIENCED NO RESTRICTION. THE PATIENT WENT IN FOR A FILL AND WERE TOLD BY THEIR PHYSICIAN THERE WAS NO FLUID IN THE BAND. THE PATIENT RETURNED A MONTH LATER AND WAS TOLD THERE WAS LESS FLUID IN THE BAND THEN WAS PUT IN. THE PATIENT HAD X-RAYS DONE THAT DID NOT SHOW A LEAK. THE PHYSICIAN TOLD THE PATIENT IT WAS MOST LIKELY A PORT LEAK, AND THE PATIENT HAD THE PORT REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 5154879 ↗
• InjuryAug 11, 2015Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED "PATIENT UNABLE TO TOLERATE FLUIDS - LAPAROSCOPY SHOWING REACTION TO BAND, ? INFECTION." PATIENT ELECTED TO HAVE BAND REMOVED. BAND WILL NOT BE REPLACED.

  Patient problems: Irritation; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 5003142 ↗
• InjuryMar 13, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THE LAP-BAND ERODED INTO THE STOMACH. THE PATIENT HAD PAIN, WAS TIRED, FELT NAUSEATED, AND WAS UNABLE TO CONSUME THE PROPER AMOUNTS OF FOOD. THE EVENTS HAVE NOT BEEN CONFIRMED BY A HEALTHCARE PROFESSIONAL. THE LAP-BAND SYSTEM WAS EXPLANTED.

  Patient problems: Adhesion(s); Erosion; Malaise; Nausea; Pain

  MAUDE report 4608469 ↗
• InjuryJan 28, 2015Inadequacy of Device Shape and/or Size

  HEALTHCARE PROFESSIONAL REPORTED THAT TWO DAYS AFTER IMPLANT, PATIENT ADMITTED TO HOSPITAL WITH AN INABILITY TO TOLERATE FLUIDS AND AN OBSTRUCTION. ORIGINAL DEVICE REMOVED AND REPLACED WITH A LARGER SIZE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 4469184 ↗
• MalfunctionJan 2, 2014Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LAP-BAND PORT HAD A "TINY HOLE" ON THE BUTTOM AND IT WAS "LEAKING". THE PATIENT FELT LIKE "NO ADJUSTMENTS WERE DONE" A FEW DAYS AFTER A PORT WA EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 3772217 ↗