BALLOON CONTROL UNIT OBCU (UDI 04953170239533)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170239533), received between Apr 5, 2022 and Aug 14, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255181 ↗
• MalfunctionMay 17, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THE BALLOON CONTROL UNIT HAD AIR PRESSURE UNSTABLE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196851 ↗
• MalfunctionApr 28, 2026Pressure Problem

  IT WAS REPORTED THAT THE BALLON CONTROL UNIT HAD AIR PRESSURE WAS NOT HOLDING. THE ISSUE OCCURRED DURING SERVICE AND MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016273 ↗
• MalfunctionOct 28, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THE SUBJECT DEVICE HAD NO PRESSURE DISPLAY DURING THERAPEUTIC ENTEROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407638 ↗
• MalfunctionSep 15, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE UNABLE TO BUILD UP PRESSURE. PRESSURE UNSTABLE. THE EVENT OCCURRED DURING SET UP BEFORE AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052095 ↗
• MalfunctionSep 6, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THE SUBJECT DEVICE'S NEGATIVE PRESSURE IS INSUFFICIENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22988968 ↗
• MalfunctionAug 22, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE ALARM WAS TRIGGERED WHEN THE MAXIMUM PRESSURE WAS EXCEEDED AND PRESSING THE BUTTON ON THE BALLOON CONTROL UNIT NEITHER STOPPED THE ALARM NOR DEFLATED THE BALLOON. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028345 ↗
• MalfunctionMar 19, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED, THE BALLOON CONTROL UNIT HAD BALLOON/PRESSURE SENSOR ISSUES, SPONTANEOUSLY DROPPED TO ZERO PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932480 ↗
• MalfunctionNov 1, 2023Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AT THE END OF AN ENTEROSOCOPY FOR ANEMIA, USING THIS BALLOON CONTROL UNIT, INFLATION PROBLEM, ABNORMAL PRESSURE WAS OBSERVED. IT PROVIDED A NEGATIVE 2 AND A DEFLATED BALLOON BUT WHEN THE HOSE WAS REMOVED, THE BALLOON WAS STILL INFLATED RESULTING IN MINIMAL MUCOSAL EROSION. THERE WAS NO DELAY IN THE PROCEDURE. NO CLINICAL AND THERAPEUTIC FINDINGS, THE PATIENT WAS DISCHARGED THE NEXT DAY. THE DEVICE WAS CHECKED BEFORE USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 18048654 ↗
• MalfunctionOct 12, 2023Pressure Problem; Pressure Problem

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE BALLOON CONTROL UNIT OLYMPUS ASSET AIR PRESSURE VALUE ABNORMAL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924533 ↗
• MalfunctionSep 21, 2023No Audible Alarm; Inflation Problem; No Audible Alarm; Inflation Problem

  NO CLEANING, DISINFECTION, AND STERILIZATION CONDITIONS BECAUSE IT IS A BOX ITEM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THE FREQUENCY OF USE OR NUMBER OF TIMES OF USE IS UNKNOWN. THE PURPOSE OF THE PROCEDURE WAS INSPECTION. INFORMATION NOT AVAILABLE ON WHAT CONGESTION TO THE MUCOUS MEMBRANE IS. NO ADDITIONAL INTERVENTION OR ADDITIONAL TREATMENT. NO HEALTH DAMAGE TO THE PATIENT DUE TO THE EVENT. ADDITIONALLY, INFORMATION RECEIVED UNSURE IF "BALLOON AIR CANNOT BE STOPPED" BUT IT DOES NOT STOP EVEN IF YOU PRESS THE PUMP PAUSE SWITCH OR IF "THE ALARM DOES NOT SOUND" THIS ONLY OCCURS IF INFLATED FOR 20 SECONDS OR MORE. UNABLE TO OBTAIN THE EXACT TIME FOR THE POWER TO BE TURNED OFF. WHEN THE USER CONNECTED THE BALLOON, IT SWELLED, AND THERE WERE NO SCRATCHES AND THERE SEEMED TO BE NO AIR LEAKAGE. THE USER DOESN¿T REMEMBER IF THERE WERE WARNING INDICATOR LAMPS ON THE MAIN UNIT AND/OR OBCU REMOTE CONTROLLER TIPPED OVER WHEN THE PHENOMENON OCCURRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17789900 ↗
• MalfunctionSep 8, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE BALLOON CONTROL UNIT AUTOMATICALLY DEFLATES ON ITS OWN. THERE WERE NO REPORTS OF PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712877 ↗
• MalfunctionDec 29, 2022Break; Mechanical Problem; Output above Specifications; Break; Mechanical Problem; Output above Specifications

  THE CUSTOMER REPORTED AN ABNORMAL SOUND (LOANER FROM OLYMPUS). NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED AS THE RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070322 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: "SINGLE BALLOON ENTEROSCOPY: IS IT FEASIBLE? PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. BACKGROUND/AIMS. CURRENTLY, TWO ENDOSCOPIC MODALITIES ARE USED TO INVESTIGATE THE SMALL INTESTINE. CAPSULE ENDOSCOPY (CE) HAS BEEN USED MAINLY AS A SCREENING TOOL FOR EVALUATING OBSCURE GASTROINTESTINAL BLEEDING. HOWEVER, CE ALSO HAS SEVERAL DISADVANTAGES, SUCH AS INADEQUATE MANIPULATION IN THE LUMEN, THE INABILITY TO TAKE TISSUE SAMPLES, AND THE INABILITY TO TREAT INTESTINAL STRICTURES. DOUBLE-BALLOON ENTEROSCOPY (DBE) AND ITS INSERTION TECHNIQUE WERE FIRST PUBLISHED BY YAMAMOTO AND COWORKERS IN 2001. ALTHOUGH DBE IS MORE INVASIVE THAN CE, DBE IS CLINICALLY A VERY USEFUL TOOL NOT ONLY FOR DIAGNOSIS, BUT ALSO FOR ENDOSCOPIC THERAPY IN THE SMALL INTESTINE.5-15 ALTHOUGH THE METHOD FOR DBE INSERTION HAS ALREADY BEEN ESTABLISHED, THERE ARE A FEW PROBLEMS IN TERMS OF PREPARATION AND INSERTION FOR DBE AS COMPARED WITH CONVENTIONAL ENDOSCOPIES. FOR EXAMPLE, DURING PREPARATION,

  Patient problems: Fever; Peritonitis; Unspecified Tissue Injury

  MAUDE report 14848615 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE TO A GASTROSCOPE DURING ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH SURGICALLY ALTERED ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-CQ260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS D-201-10704. BACKGROUND/AIMS: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH SURGICALLY ALTERED ANATOMY (SAA) IS CHALLENGING TO GASTROINTESTINAL ENDOSCOPISTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE (SBE) TO A GASTROSCOPE DURING SBE-ASSISTED ERCP (SBE-ERCP) IN PATIENTS WITH SAA. METHODS: PATIENTS WHO UNDERWENT SBE-ERCP BETWEEN FEBRUARY 2019 AND OCTOBER 2020 WERE RETROSPECTIVELY IDENTIFIED. INTUBATION SUCCESS, SCOPE EXCHANGE SUCCESS, CANNULATION SUCCESS, AND THERAPEUTIC SUCCESS WERE ANALYZED ALONG WITH COMPLICATIONS. RES

  Patient problems: Perforation

  MAUDE report 14760302 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "WATER EXCHANGE-ASSISTED VS. CARBON DIOXIDE-INSUFFLATED SINGLE-BALLOON ENTEROSCOPY: RANDOMIZED CONTROLLED TRIAL" BY SHUHUI LIANG, ET AL.   ABSTRACT: BACKGROUND SINGLE-BALLOON ENTEROSCOPY (SBE) IS A VALUABLE BUT DIFFICULT MODALITY FOR THE DIAGNOSIS AND TREATMENT OF SMALL-BOWEL DISEASE. THE WATER EXCHANGE METHOD HAS THE ADVANTAGE OF FACILITATING INTUBATION DURING COLONOSCOPY. HERE, WE EVALUATED THE EFFECTS OF WATER EXCHANGE ON PROCEDURE-RELATED VARIABLES RELATED TO SBE. METHODS THIS RANDOMIZED CONTROLLED TRIAL WAS CONDUCTED IN A TERTIARY-CARE REFERRAL CENTER IN (B)(6). PATIENTS DUE FOR ATTEMPTED TOTAL ENTEROSCOPY WERE RANDOMLY ALLOCATED TO UNDERGO WATER EXCHANGE-ASSISTED (WATER EXCHANGE GROUP) OR CARBON DIOXIDE-INSUFFLATED ENTEROSCOPY (CO2 GROUP). ALL PATIENTS WERE PLANNED TO UNDERGO BOTH ANTEROGRADE AND RETROGRADE PROCEDURES. THE PRIMARY OUTCOME WAS THE TOTAL ENTEROSCOPY RATE. SECONDARY OUTCOMES INCLUDED THE MAXIMAL INSERTION DEPTH, POSITIVE FINDINGS, PROCEDURAL TIME, AND ADVERSE EVENTS. RESULTS: IN TOTAL, 110 PATIENTS WERE ENROLLED, WITH 55 IN EACH GROUP. BASELINE CHARACTERISTICS BETWEEN THE TWO GROUPS WERE COMPARABLE. TOTAL ENTERO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14014189 ↗