LAP-BAND AP Adjustable Gastric Banding SystemRecalls & reported problems across all models
Apollo Endosurgery, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 136
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls
- 0
We found 4 models of LAP-BAND AP Adjustable Gastric Banding System by Apollo Endosurgery, Inc. in the FDA's device registry (GUDID). Together they are named in 136 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2014 and Jun 18, 2019 — classified as 79 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported LAP-BAND AP Adjustable Gastric Banding System problems
Device problems
- Fluid/Blood Leak45
- Adverse Event Without Identified Device or Use Problem44
- Leak/Splash16
- Device Slipped10
- Appropriate Device Problem Term/Code Not Available4
- Inadequacy of Device Shape and/or Size3
- Insufficient Device Problem Information3
- Migration or Expulsion of Device3
Patient problems
- Failure of Implant32
- Patient Problem/Medical Problem32
- Dysphagia/ Odynophagia26
- Pain24
- Regurgitation24
- Vomiting18
- Erosion11
- Nausea9
LAP-BAND AP Adjustable Gastric Banding System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LAP-BAND AP Adjustable Gastric Banding System B-2240Implant, Intragastric For Morbid Obesity82 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2245Implant, Intragastric For Morbid Obesity27 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2260Implant, Intragastric For Morbid Obesity18 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2265Implant, Intragastric For Morbid Obesity9 reports
Recent LAP-BAND AP Adjustable Gastric Banding System adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Apollo Endosurgery, Inc. products
All Apollo Endosurgery, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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