The LAP-BAND Adjustable Gastric Banding SystemRecalls & reported problems across all models
Apollo Endosurgery, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 3 models of The LAP-BAND Adjustable Gastric Banding System by Apollo Endosurgery, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2011 and Dec 19, 2018 — classified as 20 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 The LAP-BAND Adjustable Gastric Banding System problems
Device problems
- Fluid/Blood Leak13
- Adverse Event Without Identified Device or Use Problem9
- Device Slipped6
- Leak/Splash6
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Kinked1
- Material Deformation1
Patient problems
- Failure of Implant13
- Regurgitation10
- Patient Problem/Medical Problem8
- Dysphagia/ Odynophagia7
- Pain7
- Vomiting6
- Erosion4
- Inflammation4
The LAP-BAND Adjustable Gastric Banding System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- The LAP-BAND Adjustable Gastric Banding System B-2220Implant, Intragastric For Morbid Obesity25 reports
- The LAP-BAND Adjustable Gastric Banding System B-2210Implant, Intragastric For Morbid Obesity6 reports
- The LAP-BAND Adjustable Gastric Banding System B-2250Implant, Intragastric For Morbid Obesity6 reports
Recent The LAP-BAND 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.
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/REFLUX AND DYSPHAGIA." THE DEVICE WAS REMOVED.
Patient problems: Dysphagia/ Odynophagia; Regurgitation
MAUDE report 8179145 ↗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 "PROGRESSIVE DYSPHAGIA, NAUSEA VOMITING AND EPIGASTRIC PAIN." THE DEVICE WAS REMOVED.
Patient problems: Dysphagia/ Odynophagia; Nausea; Pain; Vomiting
MAUDE report 8178890 ↗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 CHRONIC BACK PAIN, GASTROESOPHAGEAL DISEASE, AND TROUBLE SWALLOWING. DEVICE WAS REMOVED.
Patient problems: Dysphagia/ Odynophagia; Pain; Regurgitation
MAUDE report 8043998 ↗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 PAIN AT LAP BAND PORT SIDE AND EPISODES OF DYSPHAGIA. DEVICE WAS REMOVED.
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 8043935 ↗MalfunctionAug 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A PORT LEAK APPROXIMATELY ONE YEAR POST PLACEMENT. THE PORT WAS REMOVED AND ANOTHER PORT PLACED. AFTER THAT, THE PATIENT REPORTS "BAND NEVER WORKED CORRECTLY AGAIN AND NEVER COULD BE ADJUSTED CORRECTLY AGAIN AND THIS CAUSED NUMEROUS UNFILLS DUE TO THE VOMITING." PATIENT REPORTS DILATION OF THE ESOPHAGUS AND NOTED ALL THE FLUID WAS REMOVED FROM THE BAND. PATIENT REPORTS THAT NOW THERE IS "STOMACH DEFORMITY DISCOVERED DURING A RECENT EGD." PATIENT ADDITIONALLY REPORTS "ACID COMES UP MY THROAT AND INTO MY SINUS." THE BAND IS SCHEDULED TO BE REMOVED.
Patient problems: Failure of Implant; Regurgitation; Unspecified Infection; Vomiting
MAUDE report 7763740 ↗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 "ABDOMINAL PAIN ISSUES GASTRIC POLYP AND MILD DISTAL ESOPHAGITIS." THE DEVICE WAS REMOVED.
Patient problems: Inflammation; Irritation; Pain
MAUDE report 7694764 ↗InjuryMay 29, 2018Device Slipped; Device Slipped
REPORTED AS: THE PATIENT HAD THEIR ENTIRE LAP-BAND SYSTEM REMOVED AS PATIENT "HAD MANY VARIOUS ILLNESS SHORTLY AFTER IT WAS IMPLANTED. IN CONSTANT PAIN, 24/7. WAS TOLD REPEATEDLY IT WAS NOT THE BAND. I FINALLY CONVINCED DOCTORS THAT WHAT [PATIENT] WAS GOING THROUGH WAS THE BAND. I HAVE HIGH LIVER LEVELS AND AM HOPING THAT THEY'LL GO DOWN NOW THAT THE BAND IS GONE. I HAVE HAD PAIN IN MY RIB AREA, STERNUM THROUGH MY BACK, COLLAR BONE, SHOULDER AND DOWN MY LEFT ARM. HOSPITALIZED TWICE FOR POSSIBLE HEART ISSUES AND MY HEART'S FINE. WAS HEAVING, THROWING UP, FATIGUED, LIVER PROBLEMS, EAR NOSE AND THROAT PROBLEMS. LOCAL DOCTORS MADE ME FEEL AS THOUGH I WAS CRAZY. I WENT THROUGH DEPRESSION, BRAIN FOG, MY SIGHT HAS BEEN AFFECTED. I HAD ALL OVER JOINT AND MUSCLE PAIN THAT LASTED 18 MONTHS. COULDN'T RAISE MY ARMS ABOVE MY HEAD. TESTED OUT THE WAZOO AND NO ARTHRITIS. MY STOMACH CAME UP THROUGH THE BAND AND CAUSED BLOCKAGE AND SEVERE PAIN. SO MUCH SCAR TISSUE ALSO."
Patient problems: Adhesion(s); Complaint, Ill-Defined; Depression; Malaise; Obstruction/Occlusion; Pain; Patient Problem/Medical Problem; Vomiting
MAUDE report 7550763 ↗InjuryMay 4, 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 "CHRONIC ISSUES OF DYSPHAGIA, REFLUX AND WEIGHT GAIN. PATIENT ALSO HAD GASTROESOPHAGEAL REFLUX DISEASE (GERD), VOMITING, AND CONSTANT NAUSEA. PATIENT WANTED TO HAVE SLEEVE." DEVICE WAS REMOVED.
Patient problems: Dysphagia/ Odynophagia; Nausea; Regurgitation; Vomiting; Weight Changes
MAUDE report 7487364 ↗InjuryMay 3, 2018Device Slipped; Device Slipped
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM REPORTED TO HAVE "PAIN AT SIDE OF PORT AND PROLAPSED BAND". DEVICE WAS REMOVED.
Patient problems: Pain
MAUDE report 7483648 ↗MalfunctionJan 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A LEAK. "[PATIENT] WENT FROM 252 TO 151 IN THE FIRST 2 YEARS AFTER PLACEMENT, THEN GRADUALLY REGAINED ABOUT 40 POUNDS, HAVING LAST SEEN [PHYSICIAN] IN 2015 FOR A "FILL" THAT [PATIENT] REPORTED HAD NO EFFECT. THE [PHYSICIAN] TRIED ADJUSTING THE BAND WITH NO SUCCESS A MONTH OR MORE AGO. THIS LED THEM TO SUSPECT A LEAKING PORT. A CT WAS PERFORMED AND THEY WERE ABLE TO 'SEE' THE INTRA-ABDOMINAL TUBING. THE CT SCAN "SHOWS TWO DISTINCT ENDS OF TUBING FREE IN THE PELVIS". DEVICE HAS BEEN REMOVED.
Patient problems: Failure of Implant
MAUDE report 7229682 ↗MalfunctionNov 21, 2017Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE BEEN "EVALUATED FOR A LAP BAND TUBING LEAK." [PATIENT] "FELT THERE WAS NO RESTRICTION AND THERE WAS MINIMAL FLUID IN [THEIR] SYSTEM. WHEN SALINE WAS INJECTED IT DID NOT RETURN FULL VOLUME. X-RAY SHOWED PROXIMAL TUBING LEAK, WHICH REQUIRED LAPAROSCOPY TO REPAIR. LEAK WAS TOO CLOSE TO BAND TO REPAIR AT LAPAROSCOPY." DEVICE WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 7049844 ↗MalfunctionNov 6, 2017Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM HAD DEVICE REMOVAL DUE TO "PORT NOT HOLDING FLUID AND GASTROESOPHAGEAL REFLUX DISEASE (GERD)".
Patient problems: Regurgitation
MAUDE report 7003748 ↗MalfunctionNov 6, 2017Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM HAD "LAP-BAND PORT MALFUNCTION. BAND WAS FILLED THEN LEAKED RIGHT AWAY". DEVICE WAS REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 7003712 ↗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 ↗MalfunctionOct 11, 2017Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH LAP-BAND SYSTEM HAD PRESENTED TO EMERGENCY ROOM (ER) DUE TO ABDOMINAL PAIN "CRAMPING" ALONG WITH NAUSEA AND DIARRHEA. X-RAY WAS PERFORMED AND ER PHYSICIAN SUSPECTED SMALL RIGHT PLEURAL EFFUSION AND LAP-BAND IN PLACE WITH NO DEVICE ADVERSE FEATURE. FIVE YEARS LATER PATIENT HAD PRESENTED TO EMERGENCY DEPARTMENT (ED) AGAIN 3 DAYS AFTER ABDOMINAL PAIN STARTED WITH PERTINENT NEGATIVES: DIARRHEA, DYSURIA, HEMATURIA, AND VOMITING. PATIENT REPORTED THEIR LAP-BAND SYSTEM WAS EXPLANTED DUE TO "DEVICE COMPLICATIONS. INFLAMED INSIDE LINING OF THE STOMACH, HOLE IN THE BAND, IT WAS BROKEN AND CAUSING BOWEL ISSUES, BEING SICK A LOT. GOING TO BATHROOM HURT A LOT BETWEEN MY LEGS WHEN I PEE. TOOK PAIN MEDICATION BUT DID NOT HELP. DEVELOPED "SCAR TISSUES THAT WERE PRETTY BIG" IN THE STOMACH, THE BAND MADE IT "HARD TO GO TO THE BATHROOM", AND WAS "BLEEDING FROM [THEIR] BEHIND"." PHYSICIAN CONFIRMED THROUGH CT SCAN AND PELVIS WITHOUT CONTRAST AND X-RAY "LAP-BAND TUBING DISCONNECTED FROM THE PORT WITH THE TIP OF THE TUBING IN LEFT LOWER PELVIS", BUT NOTED PATIENT'S SEVERE PELVIC PAIN WAS NOT RELATED TO THE TUBING. PHYSICIAN REMOVED THE ENTIRE LAP-BAND SYSTEM AS THE PATIENT HA
Patient problems: Abdominal Pain; Diarrhea; Dysuria; Hematuria; Inflammation; Nausea; Patient Problem/Medical Problem; Pleural Effusion; Scar Tissue; Vomiting
MAUDE report 6942635 ↗
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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