ORBERA Intragastric Balloon System B-4800Recalls & reported problems

Summary

The FDA's MAUDE database contains 327 adverse event reports that list this exact device (DI 10811955020619), received between Oct 7, 2015 and Dec 23, 2025 — classified as 6 deaths, 195 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (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, 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 327 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA INTRAGASTRIC BALLOON SYSTEM WAS USED DURING AN IMPLANT PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS A LEAK IN THE BALLOON. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883270 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAN AN ORBERA BALLOON WAS USED FOR AN INTRAGASTRIC BALLOON IMPLANT PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A TORN SHEATH PRIOR TO PULLING IT OUT OF THE PACKAGE. NO EXTRA BALLOON WAS ON HAND AND THE PROCEDURE WAS RE-SCHEDULED AND SUCCESSFULLY COMPLETED ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121905 ↗
• MalfunctionFeb 11, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA INTRAGASTRIC BALLOON SYSTEM WAS USED DURING AN INTRAGASTRIC BALLOON PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. IN PREPARATION OF THE DEVICE, UPON OPENING THE PACKAGING, THE ORBERA BALLOON WAS OBSERVED TO BE PARTIALLY DEPLOYED. PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED. PROCEDURE WAS CANCELLED AND RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360243 ↗
• InjuryFeb 5, 2025Material Integrity Problem; Material Integrity Problem

  REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD NAUSEA AND VOMITING AT APPROXIMATELY 5 MONTHS POST PLACEMENT. MEDICATION WAS PRESCRIBED TO ADDRESS PATIENT'S SYMPTOMS; HOWEVER, THEY DID NOT RESOLVE. PATIENT THEN MADE OFFICE AWARE OF ACUTE EPIGASTRIC PAIN AND ARRANGEMENTS WERE MADE TO REMOVE THE ORBERA. UPON REMOVAL OF THE ORBERA, IT WAS NOTED THAT THE PATIENT HAD ULCERS PRESENT IN THE STOMACH AND ALSO NOTED UPON REMOVAL THAT THERE WERE SOME VISUAL "IRREGULARITIES" OF THE BALLOON SHELL.

  Patient problems: Abdominal Pain; Nausea; Ulcer; Vomiting

  MAUDE report 21313194 ↗
• InjuryJun 25, 2024Deflation Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ORBERA365 INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON (B)(6), 2023. IT WAS REPORTED THAT THE PATIENT REPORTED BEING HUNGRY ALL THE TIME (LOSS OF SATIETY, INCREASED HUNGER) AND WEIGHT GAIN. AN ENDOSCOPIC PROCEDURE WAS PERFORMED ON (B)(6) 2024 AS THE PHYSICIAN REPORTED SYMPTOMS MAY BE INDICATIVE OF BALLOON DEFLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Weight Changes

  MAUDE report 19610175 ↗
• InjuryJun 18, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ORBERA INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH NAUSEA, VOMITING, ABDOMINAL PAIN, AND DEHYDRATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH NAUSEA AND VOMITING. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE TWO (2) CT SCANS AND A EGD WERE PERFORMED. ON (B)(6) 2024, THE BALLOON WAS REMOVED, AND THE PATIENT DISCHARGED. THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED. IT WAS REPORTED THAT METHYLENE BLUE WAS USED WHEN FILLING THE ORBERA BALLOON. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE IGB IS PLACES IN THE STOMACH AND FILLED WITH STERILE SALINE.

  Patient problems: Abdominal Pain; Dehydration; Discomfort; Nausea; Vomiting

  MAUDE report 19558695 ↗
• MalfunctionFeb 27, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA INTRAGASTRIC BALLOON SYSTEM WAS USED DURING AN INTRAGASTRIC BALLOON PLACEMENT PROCEDURE USED TO TREAT OBESITY PERFORMED ON (B)(6) 2024, WHICH WAS PERFORMED UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE PHYSICIAN WENT TO INFLATE THE BALLOON AND IT DID NOT INFLATE. THE PROCEDURE WAS RESCHEDULED FOR WHEN REPLACEMENT BALLOON ARRIVES. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791138 ↗
• MalfunctionFeb 6, 2024Fluid/Blood Leak; Difficult to Remove; Fluid/Blood Leak; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ORBERA INTRAGASTRIC BALLOON SYSTEM WAS USED IN AN INTRAGASTRIC BALLOON INSERTION PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS NOT FILLING PROPERLY AND FLUID LEAKED FROM THE BALLOON INTO THE STOMACH. AS A RESULT, IT WAS NECESSARY TO EXTRACT THE BALLOON, HOWEVER IT WAS DIFFICULT TO EXTRACT THE BALLOON THROUGH THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650139 ↗
• InjuryDec 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA INTRAGASTRIC BALLOON SYSTEM WAS IMPLANTED ON (B)(6) 2023 FOR WEIGHT LOSS. AFTER THE PROCEDURE, THE PATIENT STARTED TO EXPERIENCE DISCOMFORT AND PAIN. THE PATIENT HAD AN ENDOSCOPY PROCEDURE ON (B)(6) 2023 AND HAD THE ORBERA INTRAGASTRIC BALLOON SYSTEM WAS EXPLANTED. IT IS NOTED THAT THE PATIENT HAS FULLY RECOVERED. **ADDITIONAL INFORMATION **** THE EXPLANT DATE IS (B)(6) 2023.

  Patient problems: Discomfort; Pain

  MAUDE report 18284630 ↗
• MalfunctionNov 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED PATIENT EXPERIENCED VOMITING AND ORAL INTOLERANCE EVERY FEW DAYS FOR THE 3 WEEKS THE IGB WAS IN HER STOMACH. THE INTOLERANCE SYMPTOMS CAUSED EXTREME FATIGUE. THE BALLOON WAS SUCCESSFULLY REMOVED.

  Patient problems: Fatigue; Vomiting

  MAUDE report 18212435 ↗
• MalfunctionNov 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED BALLOON PLACED AND THEN, STARTING THE SECOND WEEK, EXPERIENCED VOMITING, DEHYDRATION, NAUSEA AND FATIGUE. BALLOON SUCCESSFULLY REMOVED.

  Patient problems: Dehydration; Fatigue; Nausea; Vomiting

  MAUDE report 18212426 ↗
• MalfunctionNov 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS ADMITTED TO THE HOSPITAL AFTER PRESENTING WITH ABDOMINAL PAIN, CRAMPING, NAUSEA, VOMITING WITH BURNING SENSATION AND UNABLE TO TOLERATE LIQUIDS SINCE PLACEMENT OF THE BALLOON. PATIENT IS DOING WELL.

  Patient problems: Abdominal Cramps; Abdominal Pain; Dehydration; Nausea; Vomiting

  MAUDE report 18068162 ↗
• MalfunctionOct 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT WAS REPORTED THROUGH A LITERATURE REVIEW ARTICLE. IT WAS REPORT THAT THE MOST COMMON ADVERSE EVENTS WERE NAUSEA AND VOMITING. THE WERE OTHER CASES MENTIONED FOR OBSTRUCTION BUT DID NOT GIVE ANY SPECIFICS. THE MANUFACTURER OF THE DEVICE WAS NOT MENTIONED IN THE ARTICLE.

  Patient problems: Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 17965377 ↗
• MalfunctionOct 2, 2023Compatibility Problem; Compatibility Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT PRESENTED WITH HEMOGLOBIN DROPPED, ANEMIA, BLEEDING AND GASTRITIS. THE BALLOON WAS SUCESSFULLY REMOVED.

  Patient problems: Anemia; Failure of Implant; Gastritis; Gastrointestinal Hemorrhage; Low Oxygen Saturation

  MAUDE report 17851357 ↗
• InjuryJul 26, 2023Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT ADMITTED TO THE HOSPITAL FOR INTOLERANCE, ABDOMINAL PAIN, VOMITING, NAUSEA, CRAMPING. BALLOON WAS REMOVED EARLY. PATIENT IS DOING FINE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Nausea; Vomiting

  MAUDE report 17396895 ↗
• MalfunctionJul 19, 2023Separation Problem; Premature Separation; Separation Problem; Premature Separation

  HEALTHCARE PROFESSIONAL REPORTED THE BALLOON SEPARATED FROM THE CATHETER WHEN PASSING THROUGH THE ESOPHAGUS. CASE WAS ABORTED AND COMPLETED THE FOLLOWING DAY. PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 17350818 ↗
• MalfunctionMay 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT PRESENTED TO EMERGENCY ROOM WITH VOMITING AND POSSIBLE TEAR OF THE ESOPHAGUS. PATIENT IS DOING WELL.

  Patient problems: Perforation of Esophagus; Vomiting

  MAUDE report 16983723 ↗
• MalfunctionMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT ADMITTED TO THE HOSPITAL AFTER COMPLAINING OF BLACK STOOL AND POSSIBLE GI BLEED ON AN UNKNOWN EVENT DATE. ENDOSCOPIC EXAM IDENTIFIED 1.5 LITERS OF FLUID AND FOOD WHICH WERE REMOVED. X-RAY IDENTIFIED ASPIRATION PNEUMONIA. DELAYED GASTRIC EMPTYING WAS ALSO DIAGNOSED. PATIENT DISCHARGED FROM HOSPITAL.

  Patient problems: Abdominal Pain; Aspiration Pneumonitis; Vomiting

  MAUDE report 16875522 ↗
• MalfunctionApr 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT HAD THE FOLLOWING SYMPTOMS: ABDOMINAL PAIN, BLOATING, GAS, HEARTBURN, STOMACH CRAMPS AND HADN'T LOST WEIGHT. THE BALLOON WAS REMOVED SUCCESSFULLY.

  Patient problems: Abdominal Pain; Flatus; Heartburn/Indigestion

  MAUDE report 16673305 ↗
• MalfunctionFeb 2, 2023Deflation Problem; Fluid/Blood Leak; Unintended Deflation; Deflation Problem; Fluid/Blood Leak; Unintended Deflation

  PATIENT NOTICED URINE WA GREEN COLORING. CONTACT DOCTOR AND AN ENDOSCOPY WAS PERFORMED AND IT WAS FOUND THAT THE BALLOON WAS DEFLATED. BALLOON WAS REMOVED SUCCESSFULLY AND NEW BALLOON WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16284328 ↗
• MalfunctionAug 16, 2022Inflation Problem; Inflation Problem

  PATIENT EXPERIANCED PAIN AND WAS FOUND THAT THE BALLOON WAS INFLATED. BALLOON WAS REMOVED AND REPLACED WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15232822 ↗
• MalfunctionJun 15, 2022Deflation Problem; Fluid/Blood Leak; Unintended Deflation; Deflation Problem; Fluid/Blood Leak; Unintended Deflation

  PATIENT DID NOT FEEL THE BALLOON. CONFIRMED BT X-RAY THE BALLOON DEFLATED. BALLOON WAS REMOVED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 14695642 ↗
• MalfunctionJan 7, 2022Inflation Problem; Inflation Problem

  PATIENT WAS HAVING NAUSEA, VOMITING WENT TO HOSPITAL WHERE A CT SCAN WAS PERFORMED AND FOUND THE BALLOON WAS INFLATED. BALLOON WAS REMOVED SUCCESSFULLY.

  Patient problems: Failure of Implant; Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 13193560 ↗
• MalfunctionOct 28, 2021Inflation Problem; Inflation Problem

  PATIENT BEGAN EXPERIENCING SEVERE NAUSEA & EMESIS, BALLOON WAS FOUND INFLATED, BALLOON WAS REMOVED FOR PATIENT SAFETY.

  Patient problems: Failure of Implant

  MAUDE report 12711280 ↗
• MalfunctionOct 26, 2021Migration; Migration

  PATIENT EXPERIENCE THE FOLLOWING SYMPTOM CHEST AND ABDOMINAL PAIN, CT SCAN SHOWED GASTRIC PERFORATION. THE BALLOON WAS REMOVED FOR PATIENT SAFETY.

  Patient problems: Failure of Implant; Perforation

  MAUDE report 12697886 ↗