LAP-BAND AP Adjustable Gastric Banding System B-2240Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10811955020183), received between Oct 8, 2014 and Jun 18, 2019 — classified as 53 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM REPORTED THE DEVICE "ERODED A HOLE IN THE STOMACH AND MIGRATED TO THE LIVER." PATIENT NOTED THAT AFTER PLACEMENT THEY EXPERIENCED PAIN AND COULDN'T SWALLOW. PATIENT WAS INFORMED THAT DURING THE PLACEMENT PROCEDURE THE PHYSICIAN HAD FILLED THE BAND. PATIENT INFORMED PHYSICIAN THAT THEY DIDN'T FEEL RIGHT, HAD NO RESTRICTIONS WITH MEALS. WHEN THE PHYSICIAN DID A FILL THE PATIENT COULDN'T FEEL IT. ALTHOUGH IT WAS NOTED WHEN THE PHYSICIAN REMOVED THE FILL THE SAME AMOUNT OF SALINE WAS REMOVED THAT WAS PUT IN. PATIENT LATER HAD ESOPHAGITIS. WHEN A PHYSICIAN REMOVED THE DEVICE IT WAS OBSERVED THE LAP-BAND WAS SERVING AS A PATCH AND A HOLE WAS NOTED. THE PATIENT HAD TO SPEND 2-3 DAYS IN THE HOSPITAL TO RECOVER FROM THE PROCEDURE.

  Patient problems: Dysphagia/ Odynophagia; Erosion; Inflammation; Internal Organ Perforation; Malaise; Pain

  MAUDE report 8709902 ↗
• InjuryApr 4, 2019Adverse 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 "CHRONIC GERD, DYSPHAGIA AND EPIGASTRIC ABDOMINAL PAIN." THE DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Pain; Regurgitation

  MAUDE report 8485339 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "LAP-BAND PORT MALFUNCTIONED AND WAS REMOVED. PORT HAD FRACTURED AND WAS BROKEN WERE IT CONNECTS TO TUBING. WAS REPLACED WITH A NEW PORT".

  Patient problems: Failure of Implant

  MAUDE report 8453990 ↗
• InjuryDec 26, 2018Device Slipped; Device Slipped

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM HAD EXPERIENCED DIFFICULTY WITH SWALLOWING, DIARRHEA AND HAD THE DEVICE REMOVED DUE TO DEVICE EROSION WHICH CORRODED INTO THE STOMACH. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) CONFIRMED EROSION. DURING THE EXPLANT SURGERY, IT WAS NOTED THE BAND HAD SLIPPED AND HAD GONE FAR DOWN THE STOMACH. PHYSICIAN HAD TO CUT THE STOMACH TO FIND THE BAND. A MONTH LATER, THE PATIENT REPORTED PAIN, SWELLING AND DRAINAGE WITH GREY OUTPUT WITH FOUL SMELL AT INCISION SITE. PATIENT HAD OPENING OF THE WOUND. OPERATIVE REPORT CONFIRMED INFECTION AND DRAINAGE OF WOUND ABSCESS. LATER PATIENT HAD REPORTED CONCERN OF BLEEDING FROM THE INCISION SITE, PAIN AROUND ABDOMEN AND DISCOMFORT AWAY FROM INCISION SITE. PER OPERATIVE REPORT, THE DISCOMFORT WAS DUE TO MUSCULAR BRUISING THAT OFTEN SHOW UP SEVERAL WEEKS AFTER THE PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN. THE INFECTION HAD DAMAGED THE MUSCLE IN THE STOMACH AND CAUSED A HUGE HERNIA. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED 6.8 CENTIMETER INCISIONAL HERNIA DEFECT IN THE UPPER MIDLINE. THE HERNIA WAS PUSHING THE INTESTINES AND OVARIES AND THEREFORE THE PATIENT HAD THE HERNIA REPAIR SURGERY. THIS EXPER

  Patient problems: Abdominal Pain; Blood Loss; Diarrhea; Dysphagia/ Odynophagia; Erosion; Fluid Discharge; Hernia; Swelling; Unspecified Infection; Vomiting; Wound Dehiscence

  MAUDE report 8197031 ↗
• InjuryDec 19, 2018Adverse 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 "GERD-CHRONIC, DYSPHAGIA AND EPIGASTRIC ABDOMINAL PAIN." THE DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Pain; Regurgitation

  MAUDE report 8178736 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM EXPERIENCED DYSPHAGIA AND REFLUX. DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 8175049 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM EXPERIENCED NAUSEA, VOMITING, EPIGASTRIC ABDOMINAL PAIN, AND PAIN AT PORT SITE. DEVICE WAS REMOVED.

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 8174582 ↗
• MalfunctionNov 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "LEAKAGE". PATIENT HAS GAINED WEIGHT DURING THE LAST SIX MONTHS AND A BARIUM SWALLOW DETERMINED A LEAK.

  Patient problems: Failure of Implant

  MAUDE report 8046535 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM EXPERIENCED GASTROESOPHAGEAL REFLUX DISEASE (GERD) AND DYSPHAGIA. DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 8043808 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM EXPERIENCED INTRACTABLE VOMITING FOR SEVERAL YEARS AND BAD REFLUX. DEVICE WAS REMOVED.

  Patient problems: Regurgitation; Vomiting

  MAUDE report 8043662 ↗
• MalfunctionSep 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE HAD THE ADJUSTABLE GASTRIC BAND PLACED IN APPROX. 11 YEARS AGO. SINCE THEN THE PATIENT HAS BEEN COMPLAINING OF HAVING PAIN IN THE PELVIC AREA FOR THE PAST FIVE MONTHS AND HAS STOMACH SPASMS THAT ARE RANDOM AND NOT ASSOCIATED WITH ANYTHING. A LAPAROSCOPIC REPLACEMENT PROCEDURE WAS PERFORMED 5 MONTHS AGO OF THE ENTIRE ADJUSTABLE GASTRIC BAND SYSTEM, THROUGH THE INCISION OF CICATRIX. THE LAP-BAND CATHETER WAS DISCONNECTED FROM THE END OF CATHETER IN PELVIS. UNABLE TO VISUALIZE PELVIC STRUCTURES DUE TO EXCESS OMENTUM. THE CICATRIX INCISED ALONG LESSER CURVE. LAP-BAND WAS EXTRACTED IN ITS ENTIRETY WHILE SLIPPING THE NEW BAND THROUGH THE OLD TRACT. ASIDE THE ADJUSTMENTS DONE AFTER PLACEMENT OF THE GASTRIC BAND IN 2007, PATIENT HAD NO OTHER COMPLAINT EXCEPT FROM THE PELVIC PAIN FOR 5 MONTHS BEFORE THIS ADMISSION.

  Patient problems: Muscle Spasm(s); Pain

  MAUDE report 7873097 ↗
• InjuryAug 30, 2018Device Slipped; Device Slipped

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A REFLUX AND A BAND SLIP. THE DEVICE WAS REMOVED.

  Patient problems: Regurgitation

  MAUDE report 7833695 ↗
• InjuryJul 17, 2018Adverse 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 "PORT PAIN AT SITE." THE DEVICE WAS REMOVED.

  Patient problems: Pain

  MAUDE report 7696645 ↗
• InjuryMay 8, 2018Adverse 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 IRRITATION OF THE LAP BAND AROUND MY STOMACH, THIS IS WHAT THE DOCTOR CALLED IT, SO HE REMOVED ALL OF THE FLUID TO LET THE IRRITATION HEAL. I WENT A COUPLE OF MONTHS AND THEN STARTED HAVING ADJUSTMENTS TO HAVE THE FLUID PUT BACK IN. IT WAS NEVER THE SAME, BUT THE DOCTOR DIDN'T SEEMED CONCERNED, SO I HAD FILLS EVERY COUPLE OF MONTHS. IN (B)(6) 2017 I HAD THE SAME ISSUE WITH STOMACH ISSUES AND WENT BACK TO THE DOCTOR, HE SAID I HAD A GASTRIC VIRUS, BUT WHEN I WENT TO MY FAMILY DOCTOR THEY SENT ME TO THE EMERGENCY ROOM. I HAD AN INFECTION AND AFTER MEDICAL TEST IT WAS DETERMINED MY LAP BAND HAD ERODED AND CAUSED AN INFECTION. THE SURGEON REMOVED MY LAP BAND, HE COMMENTED IT TOOK HIM LONGER BECAUSE HE HAD A HARD TIME FINDING IT."

  Patient problems: Erosion; Irritation; Unspecified Infection

  MAUDE report 7496729 ↗
• InjuryMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: A PATIENT WITH LAP-BAND SYSTEM HAD "DRY HIVES, VOMITING, REFLUX." PATIENT WAS HOSPITALIZED AND THE DEVICE WAS REMOVED.

  Patient problems: Regurgitation; Vomiting

  MAUDE report 7484911 ↗
• InjuryMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE PATIENT HAD THEIR LAP-BAND SYSTEM REMOVED DUE TO "GASTRITIS WITH EROSION AND WOULD LIKE TO CONVERT TO A SLEEVE."

  Patient problems: Erosion; Gastritis

  MAUDE report 7484755 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE PATIENT'S LAP-BAND SYSTEM WAS EXPLANTED DUE TO "DYSPHAGIA AND VOMITING".

  Patient problems: Dysphagia/ Odynophagia; Vomiting

  MAUDE report 7244540 ↗
• MalfunctionFeb 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LOSS OF RESTRICTION. IT WAS NOTED THAT THE DEVICE HAD LOST FLUID. THE PORT WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 7244148 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE PATIENT HAD THEIR ENTIRE LAP-BAND SYSTEM REMOVED DUE TO "INTOLERANCE TO ADJUSTMENTS AND DYSPHAGIA WITH BASE".

  Patient problems: Dysphagia/ Odynophagia; Patient Problem/Medical Problem

  MAUDE report 7003924 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE PATIENT HAD THEIR ENTIRE LAP-BAND SYSTEM REMOVED DUE TO "CHRONIC ISSUE WITH DYSPHAGIA".

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 7003435 ↗
• InjuryOct 23, 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 AN EROSION. THE BAND ERODED INTO THE PATIENT'S STOMACH. DEVICE IS SCHEDULED TO BE REMOVED.

  Patient problems: Erosion

  MAUDE report 6969954 ↗
• MalfunctionOct 19, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. THE PATIENT REPORTED, "CORD PART CAME LOOSE AND WAS CAUSING IN STOMACH AREA AND FELT LIKE [PATIENT] HAD TO USE THE BATHROOM, PAIN FELT LIKE BEING PREGNANT." PATIENT WENT TO THE EMERGENCY ROOM AND A CAT SCAN AND MRI WERE PERFORMED. IT WAS NOTED THE PATIENT PRESENTED TO THE PHYSICIAN WITH BILATERAL LOWER QUADRANT ABDOMINAL PAIN. DURING THE EXAMINATION IT WAS NOTED THAT THE ABDOMEN REVEALED SOME ADHESIONS. "THE ABDOMINAL WALL PORT SYSTEM DOES NOT APPEAR TO BE CONNECTED DIRECTLY TO THE REMAINDER OF THE LINE INTRA-ABDOMINALLY." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 6962757 ↗
• InjuryAug 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: THE PATIENT'S LAP-BAND SYSTEM WAS REMOVED DUE TO "DYSPHASIA".

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 6774433 ↗
• MalfunctionJul 25, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE DEFECTIVE TUBING. "A PORT SITE REVISION WAS PERFORMED AND A TEAR IN THE TUBING WAS DISCOVERED. PHYSICIAN TRIMMED THE TUBING AND REATTACHED SUCCESSFULLY TO PORT."

  Patient problems: Failure of Implant

  MAUDE report 6742225 ↗
• MalfunctionJul 11, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: THE PATIENT HAD THEIR LAP-BAND SYSTEM REMOVED DUE TO "LEAKING LAP BAND. SUPPOSED TO HAVE 7.5 CC FOUND 6.8 CC. PATIENT FEELING HUNGER".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6703883 ↗