The LAP-BAND Adjustable Gastric Banding System B-2250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10811955020206), received between Oct 15, 2015 and Oct 24, 2017 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A SERIES OF "COMPLICATIONS". TWO YEARS AFTER THE BAND PLACEMENT, THE PATIENT HAD A FLIPPED PORT THAT WAS REVISED. ANOTHER TWO AND A HALF YEARS LATER, THE PORT FLIPPED AGAIN, WHICH WAS REVISED. FIVE MONTHS LATER THE PATIENT WAS TREATED FOR AN ABSCESS AROUND THE PORT. THE PHYSICIAN REMOVED THE PORT IN ORDER FOR THE AREA TO HEAL AND THE PATIENT WAS REINSERTED WITH A NEW PORT THREE MONTHS LATER. FIVE YEARS LATER THE "PATIENT WAS IN A REHAB HOSPITAL FOR COMPLICATIONS FROM PANNICULITIS AND [THE] PHYSICIAN REQUESTED AN EGD BE DONE AND THE BAND WAS FOUND TO BE ERODED INTO THE STOMACH." THE DEVICE WAS REMOVED.

  Patient problems: Abscess; Erosion; Inflammation

  MAUDE report 6974751 ↗
• InjuryJan 26, 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 "PRESENTED TO THE HOSPITAL ON [DATE] WITH A GI BLEED. [PATIENT] WAS PLACED ON IV FLUIDS, HEMOGLOBIN WERE TRENDED AND A PROTONIX INFUSION WAS STARTED. GI WAS CONSULTED AND AN EGD WAS PERFORMED. THE EGD SHOWED THAT THE LAP BAND HAD PERFORATED THROUGH THE GASTRIC WALL CAUSING THE BLEEDING. THE PATIENT WAS TRANSFERRED TO ICU AND A SURGICAL CONSULT WAS PLACED. SURGERY DECIDED TO DO A COMBINED LAPAROSCOPIC AND ENDOSCOPIC APPROACH TO REMOVE THE BAND AND TUBING. THE BAND AND TUBING HAD ERODED INTO THE STOMACH AND A PORTION OF THE DUODENUM. THE PATIENT HAD EXTENSIVE ADHESIONS." THE DEVICE WAS REMOVED.

  Patient problems: Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 6281814 ↗
• MalfunctionAug 9, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "NO RESTRICTION AND BEGAN GAINING WEIGHT. [PATIENT] WENT IN FOR 2 OR 3 FILLS WITH NO IMPROVEMENT. DIAGNOSTIC TEST SHOWED THERE WAS A DISCONNECTED TUBING NEAR THE BAND." REVISION SURGERY HAS NOT TAKEN PLACE AT THIS TIME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5856989 ↗
• InjuryOct 22, 2015Leak/Splash

  REPORTED AS: THE PATIENT HAD THE ENTIRE LAP-BAND SYSTEM REMOVED DUE TO A DEVICE LEAK. THE PATIENT HAD WEIGHT REGAIN AND COMORBIDITY, AND THE LAP-BAND SYSTEM WAS REMOVED WITHOUT REPLACEMENT. FOLLOW UP FOUND THAT PRIOR TO THIS EVENT, THE PATIENT HAD A PORT REMOVAL AND REPLACEMENT ON (B)(6) 2009 DUE TO A "LEAK" AND A "KINK IN THE TUBING." THIS REPORT IS FOR THE EXPLANT OF THE ORIGINAL BAND, AND FOR THE EXPLANT OF THE ORIGINAL PORT.

  Patient problems: Regurgitation; Weight Changes

  MAUDE report 5167594 ↗
• InjuryOct 16, 2015Leak/Splash

  REPORTED AS: THE PATIENT WAS NOTED TO HAVE WEIGHT GAIN. THE PHYSICIAN ACCESSED THE PORT AND ONLY FOUND 4CC INSTEAD OF 11CC IN THE PATIENT'S LAP-BAND SYSTEM. IT WAS DETERMINED TO BE A DEVICE LEAK, AND THE LAP-BAND SYSTEM WAS EXPLANTED.

  Patient problems: Failure of Implant; Weight Changes

  MAUDE report 5157203 ↗
• InjuryOct 15, 2015Leak/Splash

  REPORTED AS: PATIENT HAD A DEVICE LEAK AND EXPLANT OF THE LAP-BAND SYSTEM. DURING A FILL THE PHYSICIAN RETRIEVED ONLY 6CC INSTEAD OF THE 11CC EXPECTED.

  Patient problems: Failure of Implant

  MAUDE report 5154877 ↗