BALLOON MAJ-1351 (UDI 04953170175619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170175619), received between Jun 4, 2019 and May 29, 2025 — classified as 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THE BALLOONS HAD HOLES IN THEM. THIS OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104011 ↗
• MalfunctionFeb 7, 2025Device Slipped; Device Slipped

  NO NEW INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338241 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  OLYMPUS RECEIVED A NOTIFICATION OF A MEDWATCH REPORT SUBMITTED BY A CUSTOMER CONCERNING OUR OLYMPUS BALLOONS. ACCORDING TO THE INITIAL REPORTER, THE BALLOON SPRUNG A LEAK DURING A PROCEDURE. REPORTEDLY, THE CUSTOMER USED 3 ADDITIONAL BALLOONS WITH THE FIRST TWO FAILING IN A SIMILAR FASHION. THE 4TH BALLOON PROVED SUCCESSFUL IN CONTINUING THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTING AS A RESULT OF THESE FAILURES. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958019 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  OLYMPUS RECEIVED A NOTIFICATION OF A MEDWATCH REPORT SUBMITTED BY A CUSTOMER CONCERNING OUR OLYMPUS BALLOONS. ACCORDING TO THE INITIAL REPORTER, THE BALLOON SPRUNG A LEAK DURING A PROCEDURE. REPORTEDLY, THE CUSTOMER USED 3 ADDITIONAL BALLOONS WITH THE FIRST TWO FAILING IN A SIMILAR FASHION. THE 4TH BALLOON PROVED SUCCESSFUL IN CONTINUING THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTING AS A RESULT OF THESE FAILURES. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIERS (B)(6) & (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957384 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  OLYMPUS RECEIVED A NOTIFICATION OF A MEDWATCH REPORT SUBMITTED BY A CUSTOMER CONCERNING OUR OLYMPUS BALLOONS. ACCORDING TO THE INITIAL REPORTER, THE BALLOON SPRUNG A LEAK DURING A PROCEDURE. REPORTEDLY, THE CUSTOMER USED 3 ADDITIONAL BALLOONS WITH THE FIRST TWO FAILING IN A SIMILAR FASHION. THE 4TH BALLOON PROVED SUCCESSFUL IN CONTINUING THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTING AS A RESULT OF THESE FAILURES. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957333 ↗
• InjurySep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE BALLOON FELL OFF THE SCOPE AND FELL INTO THE LARYNGEAL MASK AIRWAY TUBE. THE BALLOON WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. REQUEST FOR ADDITIONAL INFORMATION WAS MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788570 ↗
• InjurySep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE BALLOON FELL OFF THE SCOPE AND FELL INTO THE LARYNGEAL MASK AIRWAY TUBE. THE BALLOON WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. REQUEST FOR ADDITIONAL INFORMATION WAS MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788553 ↗
• MalfunctionAug 31, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THE BALLOON RUPTURED. THE EVENT OCCURRED WHEN PREPARING THE DEVICE FOR USE IN A THERAPEUTIC PROCEDURE. THE CUSTOMER DISCARDED THE DEVICE AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659899 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT HE HAD FOUR OLYMPUS BALLOONS THAT HAD CRACKS NOTED DURING PROCEDURE PREPARATION. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS IS EVENT 3 OF 4. FOR THE RELATED CASES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450576 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT HE HAD FOUR OLYMPUS BALLOONS THAT HAD CRACKS NOTED DURING PROCEDURE PREPARATION. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS IS EVENT 4 OF 4. FOR THE RELATED CASES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450493 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT HE HAD FOUR OLYMPUS BALLOONS THAT HAD CRACKS NOTED DURING PROCEDURE PREPARATION. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS IS EVENT 2 OF 4. FOR THE RELATED CASES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450376 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT HE HAD FOUR OLYMPUS BALLOONS THAT HAD CRACKS NOTED DURING PROCEDURE PREPARATION. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS IS EVENT 1 OF 4. FOR THE RELATED CASES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450341 ↗
• InjuryJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THE BALLOON CAME OFF THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE, FELL INTO THE PATIENT AND REQUIRED RETRIEVAL DURING AN EBUS PROCEDURE. IN ADDITION, THE USER HAD DIFFICULTY PASSING THE NEEDLE DURING THE BIOPSY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17094464 ↗
• InjuryJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THE BALLOON CAME OFF THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE, FELL INTO THE PATIENT AND REQUIRED RETRIEVAL DURING AN EBUS PROCEDURE. IN ADDITION, THE USER HAD DIFFICULTY PASSING THE NEEDLE DURING THE BIOPSY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17094447 ↗
• InjuryMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE BALLOON FELL OFF THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE INTO THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE BALLOON WAS RETRIEVED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE CUSTOMER WAS UNABLE TO PROVIDE MORE INFORMATION. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - BALLOON. (B)(6) - BRONCHOFIBERVIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924245 ↗
• InjuryMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE BALLOON FELL OFF THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE INTO THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE BALLOON WAS RETRIEVED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE CUSTOMER WAS UNABLE TO PROVIDE MORE INFORMATION. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - BALLOON, (B)(6) - BRONCHOFIBERVIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924200 ↗
• MalfunctionApr 21, 2022Material Separation; Material Separation

  IT WAS REPORTED BY THE CUSTOMER, DURING A DIAGNOSTIC BRONCHIAL ULTRASOUND PROCEDURE, THE NEW BALLOON HAD FALLEN OFF THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE AND WAS RETRIEVED. NO PATIENT HARM REPORTED. THE FACILITY BELIEVED THAT THE BALLOON MAY HAVE BEEN TOO SMALL IN DIAMETER FOR THE SCOPE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE, BF-UC190F).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14172620 ↗
• MalfunctionFeb 8, 2021Separation Problem; Separation Problem

  IT WAS REPORTED, AN OLYMPUS BALLOON DEVICE WAS NOT PROPERLY STAYING FIXED TO THE SCOPE. ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN WAS HAVING DIFFICULTY WITH THE BALLOON ROLLING OFF THE END AND NOT STAYING ON THE SCOPE PROPERLY. AT THIS TIME THERE WAS NO REPORT OF PATIENT HARM OR CONSEQUENCE AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11296679 ↗
• MalfunctionOct 14, 2020Break; Break

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION ABOUT THE EVENT. THE USER FACILITY FURTHER REPORTED THE FOLLOWINGS: THE USER INSPECTED THE DEVICE BEFORE THE PROCEDURE TO CONFIRM THAT THE DEVICE WAS NORMAL. THE REPORTED EVENT THAT THE SEVERAL BALLOONS BURST WAS FOUND DURING AN ENDOBRONCHIAL ULTRASONOGRAPHY (EBUS) IN THE ANESTHETIZED PATIENT. THE FIRST BALLOON BURST INSIDE THE PATIENT. THE BALLOON OR ITS FRAGMENTS WERE SUCCESSFULLY REMOVED WITH FORCEPS. THE USER REPLACED THE BALOONS TO ANOTHER BALLOONS OF A NEW PACK AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE TOOK LONGER THAN PLANNED, BUT THE PROCEDURE DID NOT LEAD TO ANY SERIOUS DETERIORATION OF THE PATIENT'S HEALTH CONDITION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

  Patient problems: No Information

  MAUDE report 10676653 ↗
• MalfunctionSep 8, 2020Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT WHEN THE USER WAS PERFORMING MEDIASTINAL LYMPH NODE PUNCTURE, BIOPSY AND LUNG LAVAGE FOR THE PATIENT, IT WAS FOUND THE SUBJECT DEVICE HAD BROKEN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505703 ↗
• MalfunctionAug 28, 2020Leak/Splash; Defective Device; Leak/Splash; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE EBUS BALLOON WAS FOUND WITH A LEAK TO THE SIDE OF THE UNIT SHOWING THAT IT WAS BROKEN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE LOT/ SERIAL NUMBER OF THE DEVICE USED WAS NOT PROVIDED. THERE WAS NO PATIENT IMPACT OR HARM WAS REPORTED DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466137 ↗
• MalfunctionJan 6, 2020Break; Break

  THE SERVICE CENTER RECEIVED A REPORT OF A MAJ-1351 BALLOON-BF-UC, LOT 95K, THAT BURST AND FRAGMENTED INTO AT LEAST TWO PIECES INTERNALLY, IN A PATIENT, DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND. THE MAJ-1351 BALLOON WAS INSPECTED PRIOR TO THE PROCEDURE AND WAS NOTED TO BE FUNCTIONING NORMALLY. THE BALLOON WAS INFLATED WITH STERILE SALINE SOLUTION. THE DEVICE WAS INFLATED TO IMPROVE THE ULTRASOUND IMAGE, THEN DEFLATED FOR REMOVAL OF THE SCOPE FROM THE ET TUBE. THE BALLOON WAS NOTED TO BE MISSING AFTER REMOVAL OF THE SCOPE FROM PATIENT¿S ET TUBE. IT WAS REPORTED THAT IT APPEARED THAT THE BALLOON SEEMED TO BURST, AS THE SCOPE WAS BEING WITHDRAWN THROUGH THE ET TUBE ADAPTOR. A SMALL PIECE OF THE BALLOON WAS DISCOVERED AT THE TOP OF THE ET TUBE JUST INSIDE THE ADAPTOR, NO OTHER PIECES WERE EVIDENT. ALL AIRWAY PASSAGES WERE THOROUGHLY EXAMINED WITH A BRONCHOSCOPE AFTER DISCOVERY AND NO OTHER FRAGMENTS WERE LOCATED. IT WAS REPORTED THAT THE BALLOON FRAGMENT WAS RETRIEVED BY THE PHYSICIAN USING FORCEPS. NO BLEEDING WAS REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THERE WAS NO ADDITIONAL MEDICAL TREATMENT, PROLONGED OBSERVATION OR HOSPITALIZATION PROVIDED TO TH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9555493 ↗
• MalfunctionDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE UNSPECIFIED PROCEDURE WITH THE BF-UC190F WITH ATTACHING THE SUBJECT DEVICE, THE SUBJECT DEVICE FELL OFF FROM THE BF-UC190F INTO THE PATIENT'S RESPIRATORY TRACT. THE USER RETRIEVED THE SUBJECT DEVICE FROM THE PATIENT USING WITH THE UNSPECIFIED FORCEPS. THE USER DISCARDED THE SUBJECT DEVICE ACCIDENTALLY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORT OTHER THAN ABOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509064 ↗
• MalfunctionAug 23, 2019Separation Problem; Separation Problem

  IT WAS REPORTED BY THE USER FACILITY THAT THE BALLOON SLIPPED OFF THE SCOPE AT SOME TIME DURING THE PROCEDURE, OR WHEN THE SCOPE WAS PLACED BACK ON THE TABLE AFTER THE PROCEDURE WAS COMPLETED. CUSTOMER PERFORMED A CHEST X-RAY AND BRONCHOSCOPY POST-PROCEDURE AND CONFIRMED THAT THE BALLOON WAS NOT LEFT IN THE PATIENT. THERE IS NO PATIENT INJURY OR ADVERSE OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928621 ↗
• MalfunctionJun 4, 2019Break; Break

  THE MANUFACTURER WAS INFORMED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, FIVE BALLOONS BROKE WHEN BEING INFLATED. THE USER FACILITY REPORTED THERE WERE NO BALLOON FRAGMENTS THAT BROKE OFF AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE BUT FROM A DIFFERENT LOT. THERE WAS NO ISSUE REPORTED WITH THE SCOPE THAT WAS USED. THERE WAS NO TREATMENT REQUIRED AND NO ADVERSE OUTCOME TO THE PATIENT REPORTED. THIS IS REPORT 5 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668028 ↗