OBALON® Balloon Kit 7500-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00859810006036), received between Mar 15, 2017 and Jun 3, 2019 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2019Leak/Splash; Leak/Splash

  A PATIENT WITH A FIRST BALLOON PLACEMENT IN (B)(6) OR (B)(6) 2018 PRESENTED TO AN ED ON (B)(6) 2019 WITH SEVERE NAUSEA, VOMITING, ABDOMINAL PAIN AND INTOLERANCE TO ORAL INTAKE THAT BEGAN FOUR DAYS PRIOR. DURING THE ENDOSCOPIC REMOVAL PROCEDURE ON (B)(6) 2019, TWO BALLOONS WERE FOUND INFLATED IN THE STOMACH AND ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE PYLORUS EXTENDING INTO THE DUODENAL BULB CAUSING A PARTIAL LUMINAL OBSTRUCTION. TWO 10 MM CLEAN BASED CRATERED ULCERS WERE FOUND IN THE ANTRUM AND PYLORUS, AND MULTIPLE CLEAN BASED ULCERS WERE FOUND IN THE DUODENAL BULB. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY AND WERE RETURNED FOR INVESTIGATION.

  Patient problems: Abdominal Pain; Nausea; Ulcer; Vomiting

  MAUDE report 8662962 ↗
• MalfunctionFeb 28, 2019Leak/Splash; Leak/Splash

  ON (B)(6) 2019, THE PATIENT REPORTED TO THEIR PRESCRIBING PHYSICIAN THAT THEY WERE HOSPITALIZED FOR A DEFLATION WITH OBSTRUCTION UNTIL THE BALLOON PASSED WITHOUT INTERVENTION. THE DEFLATED BALLOON THAT PASSED WAS NOT RETURNED TO OBALON FOR INVESTIGATION. THE BALLOONS HAD BEEN IMPLANTED GREATER THAN THE LABELED 6 MONTHS USE WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2017, SECOND BALLOON PLACEMENT OF (B)(6) 2017, AND A THIRD BALLOON PLACEMENT OF (B)(6) 2017. THE PATIENT WAS SEEN BY A REFERRED GI FOR REMOVAL OF THE REMAINING TWO BALLOONS ON (B)(6) 2019 AND IS SCHEDULED FOR REMOVAL ON (B)(6) 2019. ON (B)(6) 2019, OBALON NOTIFIED THE PRESCRIBING PHYSICIAN'S PRACTICE MANAGER OF CONCERNS FOR DELAYING THE REMOVAL FOR ANOTHER MONTH DUE TO THE POTENTIAL RISK OF ANOTHER BALLOON DEFLATION AND SUBSEQUENT SERIOUS INJURY. ON (B)(6) 2019 THE PRACTICE MANAGER EMAILED THE PATIENT ASKING IF THERE WAS A REASON THE BALLOONS COULD NOT BE REMOVED SOONER CONSIDERING THE ADVERSE EFFECTS THAT WERE EXPERIENCED AND A RESPONSE FROM THE PATIENT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 8378189 ↗
• InjuryFeb 22, 2019Leak/Splash; Leak/Splash

  ON (B)(6) 2019, THE SPOUSE OF A PATIENT WITH TWO BALLOONS IMPLANTED CALLED TO CANCEL A SCHEDULED OVERDUE ENDOSCOPIC BALLOON REMOVAL FOR (B)(6) 2019. IT WAS REPORTED THAT A DEFLATED BALLOON WAS IDENTIFIED AND THE BALLOONS HAD BEEN REMOVED. THE BALLOONS WERE IMPLANTED GREATER THAN THE LABELED 6 MONTHS USE WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018 AND SECOND BALLOON PLACEMENT OF (B)(6) 2018. THE BALLOONS WERE NOT RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT WAS PREVIOUSLY IDENTIFIED BY THE PRESCRIBING PHYSICIAN'S SITE AS BEING OVERDUE FOR THEIR BALLOON REMOVAL AND STATED THAT THE PATIENT HAD BEEN UNRESPONSIVE TO PHONE CALLS AND EMAILS. ON (B)(6) 2018, THE PATIENT STATED TO THE PRESCRIBING PHYSICIAN'S OFFICE THAT THEY WANTED TO LEAVE THE BALLOONS IN UNTIL AFTER AN EVENT IN (B)(6). OBALON RECOMMENDED THAT THE BALLOONS BE REMOVED AS SOON AS POSSIBLE DUE TO THE OVERDUE REMOVAL DATE AND POTENTIAL RISK OF DEFLATION. THE PATIENT HAD PREVIOUSLY BEEN CONTACTED BY THE PRESCRIBING PHYSICIAN'S OFFICE WITH EMAILS, VOICEMAIL'S, AND CERTIFIED AND NON-CERTIFIED LETTERS SENT ON (B)(6) 2018 REGARDING THE PATIENT BEING OVERDUE FOR BALLOON REMOVAL. THE PATIENT CONTACTED A DIFFERENT PHYSICIAN ON

  Patient problems: Abdominal Pain; Nausea; No Information; Obstruction/Occlusion; Sleep Dysfunction; Vomiting

  MAUDE report 8362522 ↗
• InjuryNov 29, 2018Leak/Splash; Leak/Splash

  A MALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 WAS SCHEDULED FOR BALLOON REMOVAL IN (B)(6) 2018 BUT CANCELLED FOUR TIMES DUE TO PERSONAL TRAVEL. ON (B)(6) 2018 THE PATIENT CONTACTED THEIR PRESCRIBING PHYSICIAN OFFICE TO RESCHEDULE THE BALLOON REMOVAL AND REPORTED A NEW ONSET OF SYMPTOMS OF NAUSEA RELATED TO HEARTBURN. BALLOON REMOVAL WAS SCHEDULED FOR (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE ED DUE TO A BALLOON DEFLATION WITH MIGRATION INTO THE JEJUNUM CAUSING A FUNCTIONAL OBSTRUCTION. THE PATIENT HAD BEEN EXPERIENCING NAUSEA, AN INABILITY TO TOLERATE PO INTAKE, AND ABDOMINAL PAIN FOR THE PAST WEEK. THE PATIENT HAD EXPERIENCED 2-3 EPISODES OF VOMITING. THE PATIENT WAS TRANSFERRED TO A SECOND ER AT THE REQUEST OF THE OBALON PRESCRIBING PHYSICIAN SO THAT THE PATIENT COULD BE UNDER THEIR DIRECT CARE. TWO INFLATED BALLOONS WERE SUCCESSFULLY REMOVED FROM THE STOMACH BY ENDOSCOPY ON (B)(6) 2018 BUT WERE DISCARDED BY THE HOSPITAL AND NOT RETURNED TO OBALON; HOWEVER, OBALON HAD REQUESTED THE RETURN OF ALL BALLOONS PRIOR TO THE ENDOSCOPIC REMOVAL FOR PRODUCT EVALUATION. ON (

  Patient problems: Abdominal Pain; Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 8116576 ↗
• MalfunctionMay 4, 2018Material Perforation; Material Perforation

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2017, SECOND BALLOON PLACEMENT OF (B)(6) 2017, AND THIRD BALLOON PLACEMENT OF (B)(6) 2017, EXPERIENCED A NEW ONSET OF SYMPTOMS OF NAUSEA SINCE APPROXIMATELY (B)(6) 2018 AND REPORTED NEW SYMPTOMS TO THE PRESCRIBING PHYSICIAN. THE PLANNED BALLOON REMOVAL SCHEDULED FOR (B)(6) 2018 WAS MOVED TO (B)(6) 2018. DURING ENDOSCOPY, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE ANTRUM OF THE STOMACH. THE DEFLATED BALLOON WAS SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION. SLIGHT ANTRAL GASTRITIS WAS OBSERVED. THE PATIENT WAS STABLE AND LATER DISCHARGED HOME. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON. THE PATIENT LOST 57 POUNDS DURING THE TREATMENT FROM A STARTING BMI OF (B)(6). THE DEFLATED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION.

  Patient problems: Nausea

  MAUDE report 7487561 ↗
• MalfunctionMay 4, 2018Leak/Splash; Leak/Splash

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2017, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018 EXPERIENCED A NEW ONSET OF SYMPTOMS OF NAUSEA AND STOMACH PAIN ON APPROXIMATELY (B)(6) 2018. THE PATIENT WENT TO ED WHILE TRAVELING ON (B)(6) 2018 AND DURING ENDOSCOPY, ONE BALLOON WAS IDENTIFIED AS DEFLATED IN THE STOMACH. THE DEFLATED BALLOON WAS SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WAS DISCARDED. THE ED DID NOT WANT TO REMOVE THE INFLATED BALLOONS SO THE REMAINING TWO INFLATED BALLOONS WERE REMOVED ON (B)(6) 2018 BY THE PRESCRIBING PHYSICIAN AND RETURNED TO OBALON FOR INVESTIGATION. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON. THE PATIENT WAS DOING WELL AFTER THE REMOVAL WITH NO ISSUES POST REMOVAL. THE PATIENT LOST 22 POUNDS DURING THE TREATMENT FROM A STARTING BMI OF (B)(6).

  Patient problems: Abdominal Pain; Nausea

  MAUDE report 7487560 ↗
• MalfunctionFeb 23, 2018Material Perforation; Material Perforation

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2017, SECOND BALLOON PLACEMENT OF (B)(6) 2017, AND THIRD BALLOON PLACEMENT OF (B)(6) 2017 HAD A ROUTINE SCHEDULED REMOVAL ON (B)(6) 2018. THE SCHEDULED REMOVAL DATE WAS MORE THAN 6 MONTHS FROM THE FIRST BALLOON PLACEMENT. DURING THE REMOVAL PROCEDURE, ONE BALLOON WAS IDENTIFIED AS DEFLATED AND WAS LOCATED IN THE STOMACH. THE DEFLATED BALLOON WAS SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION. THE STOMACH APPEARED NORMAL. THE PATIENT HAD EXPERIENCED A NEW ONSET OF MINOR CRAMPING AT NIGHT WHEN FALLING ASLEEP ABOUT ONE WEEK PRIOR TO THE REMOVAL.. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON. THE PATIENT WAS DOING WELL AFTER THE REMOVAL WITH NO ISSUES POST REMOVAL. THE DEFLATED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION.

  Patient problems: Abdominal Cramps

  MAUDE report 7293252 ↗
• MalfunctionDec 6, 2017Material Perforation; Material Perforation

  A FEMALE PATIENT WITH THREE BALLOONS IMPLANTED, FIRST BALLOON PLACED ON (B)(6) 2017, SECOND BALLOON PLACED ON (B)(6) 2017 AND THIRD BALLOON PLACED (B)(6) 2017, HAD A REMOVAL SCHEDULED FOR (B)(6) 2017. APPROXIMATELY 2 WEEKS PRIOR TO REMOVAL, THE PATIENT REPORTED A SUDDEN ONSET OF SYMPTOMS INCLUDING CRAMPING AND VOMITING. ON (B)(6) 2017, THE PHYSICIAN BROUGHT THE PATIENT IN FOR A FLUOROSCOPIC EVALUATION AND ALL THREE BALLOONS APPEARED INFLATED AND FLOATING AT THE TOP OF THE STOMACH. THE PATIENT REPORTED RESOLUTION OF SYMPTOMS SHORTLY THEREAFTER. THE BALLOONS WERE REMOVED PER THE SCHEDULED ENDOSCOPY APPOINTMENT ON (B)(6) 2017 WITHOUT ISSUE. IT WAS DOCUMENTED AND REPORTED TO OBALON THAT DURING THE REMOVAL ONE OF THE THREE BALLOONS WAS OBSERVED TO BE UNDERINFLATED. THE REPORTED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT LOST 21.4 POUNDS AND THERE WERE NO SERIOUS INJURIES REPORTED.

  Patient problems: Abdominal Cramps; Nausea

  MAUDE report 7088239 ↗
• MalfunctionNov 3, 2017Material Rupture; Material Rupture

  A FEMALE PATIENT WITH A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2017 HAD A SECOND BALLOON PLACED ON (B)(6) 2017. DURING THE SECOND BALLOON PLACEMENT X-RAY IT WAS NOTICED THAT THE FIRST BALLOON WAS DEFLATED AND FLOATING ON TOP OF THE STOMACH FLUIDS. THE PATIENT REQUESTED THAT ONLY THE DEFLATED BALLOON BE REMOVED AND THAT THE INFLATED BALLOON REMAIN IMPLANTED TO CONTINUE WITH THE BALLOON THERAPY. THE DEFLATED BALLOON WAS SUCCESSFULLY REMOVED BY ENDOSCOPY FROM THE PATIENT'S STOMACH WITHOUT ISSUE THE NEXT DAY. THE DEFLATED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT HAD EXPERIENCED SOME NAUSEA A FEW DAYS PRIOR TO THE SECOND BALLOON PLACEMENT BUT HAD THOUGHT IT WAS MILD IN NATURE AND DID NOT CONTACT THEIR PHYSICIAN. THERE WAS NO SERIOUS INJURY DUE TO THE DEFLATED BALLOON. THE FIRST BALLOON IMPLANTATION MEDICAL RECORD WAS REQUESTED AND THE BALLOON INFLATION PRESSURE AND STABILIZATION WERE NOT RECORDED. PER THE LABELING, PATIENTS REPORTING A LOSS OF FULLNESS, INCREASED HUNGER, AND/OR WEIGHT GAIN SHOULD BE EXAMINED BY RADIOGRAPH, AS THIS MAY BE A SIGN OF BALLOON DEFLATION. ADDITIONALLY, ANY INCREASE IN NAUSEA, VOMITING AND/OR CRAMPING AFTER INITIAL SYMPTOMS HAVE SUBSIDE

  Patient problems: Nausea

  MAUDE report 6998515 ↗
• InjurySep 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WITH THREE BALLOONS WERE IMPLANTED: FIRST IMPLANTATION DATE OF (B)(6) 2017, SECOND IMPLANTATION DATE OF (B)(6) 2017, AND THIRD IMPLANTATION DATE OF (B)(6) 2017, AND WAS PRESCRIBED CONCOMITANT MEDICATION THERAPY AT EACH BALLOON PLACEMENT OF PROTONIX AND ANASPAZ FOR STOMACH CRAMPS. ON (B)(6) 2017, THE PATIENT WAS PRESCRIBED CARAFATE ADDITIONALLY FOR CRAMPING. THE PATIENT EXPERIENCED FLU LIKE SYMPTOMS ON (B)(6) 2017 AND THE PATIENT TOOK OVER THE COUNTER COUGH AND COLD MEDICINE. AFTER THE PATIENT'S COLD, THE PATIENT BEGAN VOMITING INTERMITTENTLY AND EXPERIENCED ABDOMINAL BURNING PAIN. THE PATIENT VISITED THE PHYSICIAN ASSISTANT AT THE PRESCRIBING PHYSICIAN'S OFFICE ON APPROXIMATELY (B)(6) 2017 TO ENSURE THE SYMPTOMS WERE NOT AS A RESULT OF A DEFLATION. ALL BALLOONS WERE VERIFIED AS INFLATED VIA C-ARM. THE PATIENT WAS PRESCRIBED ZOFRAN TO ADDRESS NAUSEA AND VOMITING BUT NOTHING WAS PRESCRIBED FOR THE BURNING AND ENDOSCOPIC VISUALIZATION WAS NOT CONDUCTED. THE PATIENT BEGAN VOMITING REGULARLY WITH CONSTIPATION AND OBSERVED STOOL OF BLACK COLOR AND FOUL SMELL. ON (B)(6) 2017, THE PATIENT HAD TRAVELLED TO ANOTHER STATE WHERE THE SYMPTOMS CONTINUED. THE PATIENT WAS ADMITTED

  Patient problems: Ulcer

  MAUDE report 6847519 ↗
• MalfunctionAug 25, 2017Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak

  THIS MEDWATCH REPORT PROVIDES THE MANUFACTURER'S INFORMATION OBTAINED FOR THE EVENT THAT WAS ALSO REPORTED PER VOLUNTARY REPORT NUMBER MW5071294. A FEMALE PATIENT WITH THREE BALLOONS IMPLANTED, FIRST IMPLANTATION DATE OF (B)(6) 2017, SECOND IMPLANTATION DATE OF (B)(6) 2017, AND THIRD IMPLANTATION DATE OF (B)(6) 2017, EXPERIENCED NEW SYMPTOMS OF ABDOMINAL PAIN AND DIARRHEA ON (B)(6) 2017 AND SYMPTOMS ENDED AFTER TWO DAYS WITHOUT TREATMENT. THE NEXT DAY ON (B)(6) 2017 THE PATIENT EXPERIENCED SYMPTOMS OF NAUSEA AND VOMITING AND CONTACTED PRESCRIBING PHYSICIAN CALL CENTER WHICH AT THE TIME DID NOT THINK THE SYMPTOMS WERE BALLOON RELATED. REMOVAL WAS SCHEDULED FOR (B)(6) 2017 SINCE THE PATIENT WAS OVERDUE FOR REMOVAL AND NO MEDICATIONS WERE PRESCRIBED. THE NEXT DAY ON (B)(6) 2017, THE PATIENT VISITED AN EMERGENCY ROOM DUE TO INCREASING PAIN BUT WAS NOT ADMITTED TO HOSPITAL. THE PATIENT WAS TREATED WITH IV FLUIDS FOR HYDRATION AND RECEIVED NAUSEA MEDICATIONS, PAIN MEDICATIONS, AND A SEDATIVE. ALL BLOODWORK WAS NORMAL, THEREFORE, CT SCAN WAS NOT PERFORMED. THE PATIENT WENT IN FOR THE BALLOON REMOVAL PROCEDURE FOR THREE BALLOONS ON (B)(6) 2017. DURING THE ENDOSCOPY, ONLY TWO BALLOONS WERE

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 6822595 ↗
• MalfunctionAug 1, 2017Burst Container or Vessel; Deflation Problem

  PATIENT HAD NEW ONSET OF NON-SERIOUS ABDOMINAL PAIN, NAUSEA, VOMITING AND CONSTIPATION LASTING 4 DAYS. AFTER HOLIDAY PATIENT CONTACTED SITE. X-RAY WAS CONDUCTED AND ONE OF TWO BALLOONS WAS DEFLATED DUE TO A BURST. BOTH BALLOONS WERE REMOVED AS PATIENT WANTED TO START A NEW SERIES OF BALLOONS.

  Patient problems: Abdominal Pain; Constipation; Nausea; Vomiting

  MAUDE report 6759218 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED VOMITING 1-3 TIMES PER DAY APPROXIMATELY 30 DAYS AFTER PLACEMENT OF THIRD BALLOON FOR 10 DAYS. CONTACTED DR. TO COMMUNICATE DISCOMFORT ON EVENING OF 10TH DAY. DR. FELT THAT THE PATIENT MUST HAVE BEEN MILD TO MODERATELY DEHYDRATED DUE TO FREQUENCY AND LENGTH OF VOMITING. ENDOSCOPY SUITE WAS CLOSED FOR EVENING SO ADMITTED TO HOSPITAL FOR REHYDRATION AND REMOVAL THE FOLLOWING MORNING. NO CHEMISTRY WAS OBTAINED. AFTER HYDRATION ALL CHEMISTRY VALUES IN NORMAL RANGE, EARLY MORNING OF THE DAY OF SCHEDULED REMOVAL.

  Patient problems: Dehydration; Discomfort; Vomiting

  MAUDE report 6648532 ↗
• MalfunctionMar 15, 2017Burst Container or Vessel; Entrapment of Device

  ON (B)(6) 2017, A FEMALE PATIENT CAME FOR A SECOND BALLOON PLACEMENT PROCEDURE. THE BALLOON CAPSULE WAS SWALLOWED AND INFLATED UNEVENTFULLY. HOWEVER DURING THE CATHETER RETRIEVAL PROCESS THE CATHETER BURST PROXIMALLY FROM THE PATIENT'S MOUTH, AND DISTALLY FROM THE CATHETER LUER. THIS BURST RESULTED IN A BREACH IN THE CLOSED LOOP GAS PATHWAY THAT LEADS TO BALLOON DEPRESSURIZATION LEAVING AN UNDERINFLATED BALLOON IN THE BODY. REPRESENTATIVES FROM OBALON RECOMMENDED THAT THE BALLOON BE REMOVED ENDOSCOPICALLY ACCORDING TO THE LABELING. THE BALLOON WAS NOT REMOVED. THE BREACHED CATHETER WAS RETURNED TO OBALON FOR INVESTIGATION. THE CATHETER WAS SENT FOR SEM AND THE ROOT CAUSE OF THE BURST WAS DUE TO A BITE IMPRESSION LOCATED DISTALLY FROM THE BURST. THE RESULTING INVESTIGATION CONCLUDED THAT THE BALLOON DOES NOT HAVE SUFFICIENT PRESSURIZATION AND SHOULD BE REMOVED IN ORDER TO MAINTAIN PATIENT SAFETY AND PREVENT SERIOUS INJURY. RADIOGRAPHS PERFORMED SHOWED THAT THE BALLOON WAS STILL IN THE FUNDIC REGION. THIS REPORT IS AN UPDATE TO THE PREVIOUS REPORT THAT INDICATES THAT THE PATIENT HAS RETURNED FOR AN ENDOSCOPIC REMOVAL. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY CLINICAL SEQUELAE. BOTH B

  Patient problems: Foreign Body In Patient

  MAUDE report 6408502 ↗