LAP-BAND AP Adjustable Gastric Banding System B-2245Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10811955020190), received between Apr 14, 2015 and Mar 8, 2019 — classified as 16 injuries, 11 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE AN "ISSUE WITH ONE OF THE LAP-BANDS." ADDITIONAL INFORMATION NOTED THE PATIENT EXPERIENCED A LEAK. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 8405654 ↗
• InjuryDec 27, 2018Migration; Migration

  FOLLOW UP FINDINGS PER REPORTER: PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR PERI-UMBILICAL PAIN. DIAGNOSTIC TESTS CONFIRMED "THERE IS A BAND ENCIRCLING THE UPPER STOMACH NEAR THE GASTROESOPHAGEAL JUNCTION WITHOUT A SIGNIFICANT GASTRIC POUCH DEMONSTRATED."

  Patient problems: Dysphagia/ Odynophagia; Pain; Vomiting

  MAUDE report 8200541 ↗
• MalfunctionNov 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "HOLE IN IT". THE DEVICE WAS REMOVED. ADDITIONAL INFORMATION NOTED THAT "A COUPLE OF MONTHS AGO" PATIENT EXPERIENCED STOMACH PAIN, DESCRIBED LIKE A RUBBER BAND BREAKING. THE PAIN WENT AWAY, HOWEVER THE PATIENT DID NOT FEEL FULL AND CONTINUED TO GAIN WEIGHT. A BARIUM SWALLOW AND X-RAY CONFIRMED THE DEVICE HAD A LEAK.

  Patient problems: Pain

  MAUDE report 8066915 ↗
• MalfunctionAug 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 7835316 ↗
• InjuryAug 30, 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 MEGAESOPHAGUS." FOLLOW UP INDICATED THE PATIENT WITH THE MEGA-ESOPHAGUS HAD DIFFICULTY SWALLOWING. THE DEVICE WAS REMOVED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 7834946 ↗
• 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 "PAIN AT PORT SIDE AND DYSPHAGIA".

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 7484615 ↗
• InjuryFeb 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 HAD REVISION SURGERY DUE TO "GASTROESOPHAGEAL REFLUX DISEASE (GERD) AND DYSPHAGIA". PATIENT HAD HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE (GERD). PORT REMOVED AND REPLACED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 7244784 ↗
• 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 11 CC AND 6 CC FOUND. PATIENT FEELING HUNGRY WITH NO RESTRICTION."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6703891 ↗
• InjuryJun 29, 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 "LAP-BAND DEVICE REMOVAL." IT WAS NOTED THAT PATIENT SUFFERED FROM PERSISTENT REFLUX DUE TO ESOPHAGITIS.

  Patient problems: Inflammation; Irritation; Regurgitation

  MAUDE report 6678007 ↗
• InjuryMay 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "FOREIGN BODY REMOVAL (PIECE OF BAND TUBING)." THE PATIENT DID NOT HAVE ANY SERIOUS INJURIES. IT WAS REPORTED THAT THE PATIENT HAD THE LAP-BAND AND THE DEVICE WAS REMOVED, HOWEVER A PIECE OF BAND TUBING REMAINED IN THE PATIENT. THE PATIENT NEEDED TO HAVE A SUBSEQUENT SURGERY TO REMOVE THE PIECE OF BAND TUBING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6538573 ↗
• InjuryApr 20, 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 "CHRONIC DYSPHAGIA AND GERD." DEVICE WAS EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 6508748 ↗
• InjuryJan 10, 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 "GERD & DYSPHAGIA." THE PATIENT'S LAP-BAND SYSTEM WAS EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia; Regurgitation

  MAUDE report 6236637 ↗
• InjuryJan 9, 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 "VOMITING AND HEARTBURN." THE PATIENT'S LAP-BAND SYSTEM WAS EXPLANTED.

  Patient problems: Heartburn/Indigestion; Vomiting

  MAUDE report 6234273 ↗
• MalfunctionDec 6, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "RECEIVED ADJUSTMENT BUT THE VOLUME CHECKS CONSISTENTLY REVEALED LESS VOLUME. SATIETY AFTER FILLS ONLY LASTED 24 HOURS AT THE MOST, THIS IS A CHARACTERISTIC FINDING OF A LEAKING TYPE II PORT." DEVICE WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 6148960 ↗
• InjuryDec 6, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION NOTED: CLINICAL PATIENT'S TWELVE MONTH POST OPERATIVE VISIT NOTED AN INCISIONAL HERNIA.

  Patient problems: Erosion; Hernia; Unspecified Infection

  MAUDE report 6147633 ↗
• MalfunctionOct 25, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "NO RESISTANCE AND STOMACH PAIN. THE PHYSICIAN ADDED AND REMOVED LIQUID. THE PATIENT WAS TOLD SHE WAS FINE AND WOULD NOT FILL THE BAND ANYMORE. THE PATIENT WAS UNHAPPY WITH THE PHYSICIAN'S RESPONSE, PATIENT WENT TO ANOTHER PHYSICIAN ON (B)(6) 2016 THAT PERFORMED AN ULTRA SOUND AND FLUOROSCOPY. THE PHYSICIAN TOLD THE PATIENT THERE WAS A LEAK IN THE BAND AND IT WOULD NEED TO BE REMOVED." DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Vomiting

  MAUDE report 6053896 ↗
• MalfunctionAug 31, 2016Device Issue; Device Issue

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

  Patient problems: No Information

  MAUDE report 5917419 ↗
• MalfunctionAug 8, 2016Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO "NOT [BE] EXPERIENCING RESTRICTION. CONTRAST WAS SHOWN TO BE LEAKING FROM THE BAND." THE DEVICE WAS EXPLANTED

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5855102 ↗
• InjuryMay 16, 2016Inadequacy of Device Shape and/or Size; Device Slipped; Inadequacy of Device Shape and/or Size; Device Slipped

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "FAILED LAP-BAND." PATIENT REPORTS THAT THEY WERE NEVER ADVISED TO THE EXTENSIVE SCAR TISSUE, THINNING OF THE STOMACH OR DAMAGE TO THE ESOPHAGUS THAT THE PATIENT COULD EXPERIENCE. THE PATIENT "NEVER HAD PROPER RESTRICTION" AND AFTER SEVERAL MONTHS THE DOCTOR IDENTIFIED THE BAND HAD SLIPPED. "THE BAND SLIPPED SEVERAL TIMES AND THEN I HAD IT REVISED." AFTER REVISION SURGERY THE PATIENT CONTINUED TO STRUGGLE WITH PROPER RESTRICTION AND HAD THE DEVICE REMOVED. PATIENT NOW STRUGGLES WITH ACID REFLUX AND HAD "A LARGE AMOUNT OF SCAR TISSUE" REMOVED TO GET THE PORT OUT. PATIENT IS CURRENTLY WAITING FOR SWELLING TO GO DOWN SO THE DOCTOR CAN DETERMINE IF ADDITIONAL DAMAGE HAS BEEN DONE. ADDITIONAL INFORMATION PROVIDED BY THE PATIENT DOES NOT KNOW IF SHE HAS DAMAGE TO THE ESOPHAGUS....AND IS WAITING TO BE SCOPED TO VERIFY IF ANY DAMAGE WAS DONE TO EITHER THE ESOPHAGUS OR STOMACH. PATIENT NOW SUFFERS FROM CHRONIC ACID REFLUX AND HAS HAD TO TAKE MEDICATION DAILY TO MANAGE IT AND THE ESOPHAGITIS. THE PATIENT'S LAP-BAND SYSTEM WAS EXPLANTED.

  Patient problems: Inflammation; Patient Problem/Medical Problem; Regurgitation

  MAUDE report 5658056 ↗
• InjuryJan 7, 2016Adverse 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 GASTRIC EROSION.

  Patient problems: Erosion

  MAUDE report 5352445 ↗
• InjuryJan 5, 2016Adverse 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 REPORTED AS GASTROESOPHAGEAL REFLUX. THE PATIENT WAS HOSPITALIZED, AND HAD THE LAP-BAND REMOVED AND CONVERTED TO A GASTRIC SLEEVE FOLLOWING "CHRONIC ISSUES WITH GERD AND ESOPHAGEAL SPASM."

  Patient problems: Muscle Spasm(s); Regurgitation

  MAUDE report 5345552 ↗
• MalfunctionOct 27, 2015Leak/Splash

  REPORTED AS: THE PATIENT COMPLAINED OF NO RESTRICTION OF THEIR LAP-BAND SYSTEM. A FLUOROSCOPY WAS PERFORMED, AND NO CAUSE FOR THE LACK OF RESTRICTION WAS IDENTIFIED. THE PHYSICIAN INJECTED 9CC INTO THE BAND, AND AT A LATER VISIT FOUND ONLY 7.4CC WERE LEFT IN THE BAND. THE LAP-BAND PORT WAS REMOVED AND REPLACED, AND A CRACK ON THE TUBING WAS FOUND AT THE END OF THE PORT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5181511 ↗
• MalfunctionAug 25, 2015Leak/Splash

  FAMILY MEMBER OF THE PATIENT REPORTED: "PATIENT FELT THE LAP-BAND STOPPED WORKING CORRECTLY, NEVER FULL." FOLLOW-UP WITH THE PATIENT CONFIRMED FAMILY MEMBER REPORT. IN ADDITION TO WEIGHT GAIN, PATIENT REPORTED THEY HAD A BARIUM SWALLOW WITH X-RAY DONE THAT SHOWED THE LAP-BAND WAS "INTACT." THEY WENT ON TO HAVE AN ADJUSTMENT WHERE THEIR PHYSICIAN ADDED 9CC TO THE BAND. TWO WEEKS LATER ONLY 4CC WAS FOUND IN THE BAND. PATIENT WAS TOLD BY THEIR PHYSICIAN THEY MUST HAVE A LINE LEAK OR PIN HOLES ON THE BAND AND IT WILL REQUIRE SURGERY TO REPLACE. TO DATE, THE PATIENT HAS NOT HAD THE BAND EXPLANTED.

  Patient problems: Failure of Implant; Weight Changes

  MAUDE report 5029491 ↗
• MalfunctionAug 21, 2015Leak/Splash

  REPORTED AS: PATIENT CAME IN FOR A FILL, SHOULD HAVE HAD 13.1 CC'S IN THEIR BAND, BUT FOUND ONLY 1 CC WHEN CHECKED. THREE CC'S WERE ADDED AND ONLY ONE WOULD RETURN. SUSPECTED LEAK. PATIENT SENT FOR PORT CHECK AT RADIOLOGY, BUT NO LEAK CONFIRMED. FOLLOW UP INFORMATION NOTED THE PATIENT HAD A REPLACEMENT OF THE PORT ONLY.

  Patient problems: Failure of Implant

  MAUDE report 5022492 ↗
• InjuryAug 19, 2015Leak/Splash

  REPORTED AS "PATIENT COMPLAINED OF NO RESTRICTION OF THE LAP-BAND. OMNIPAQUE INJECTION SHOWED THERE WAS A HOLE ON THE LAP-BAND. LAP-BAND WAS EXPLANTED." REPORTER DESCRIBED THERE BEING A HOLE BETWEEN THE PORT AND THE CONNECTOR OF THE BAND, REPORTING "IT LOOKS COMPLETELY CUT OFF, ERODED." FURTHER CLARIFICATION CONFIRMED THE ENTIRE SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT.

  Patient problems: Failure of Implant

  MAUDE report 5016154 ↗