BALLOON MAJ-1351 (UDI 04953170360459)Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 04953170360459), received between Jul 25, 2018 and Mar 2, 2026 — classified as 45 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (51 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 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Detachment of Device or Device Component

  MEDWATCH REPORT MW5181872 RECEIVED AND REPORTED THE FOLLOWING: PATIENT WAS UNDERGOING A BRONCHOSCOPY USING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPE (EBUS). AT THE END OF THE PROCEDURE, IT WAS IDENTIFIED THAT THE EBUS BALLOON WAS MISSING. THE PATIENT UNDERWENT AN ADDITIONAL BRONCHOSCOPY X 2, ENDOSCOPY X 1 AND CT OF CHEST WITH NO RETAINED BALLOON IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER: THE INITIAL PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND WAS PROLONGED FOR APPROXIMATELY ONE HOUR TO SEARCH FOR THE MISSING BALLOON. THE REPORTED PROBLEM NO AFFECT THE DIAGNOSTIC OUTCOME OF THE PROCEDURE. THIS REPORT IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492080 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364075 ↗
• InjuryJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE BALLOON WAS NOTICED MISSING DURING BED SIDE SCOPE CLEAN. IT WAS DETACHED FROM THE BRONCHOVIDEOSCOPE. THE PATIENT WAS BROUGHT BACK FROM THE RECOVERY ROOM BACK INTO PROCEDURE ROOM FOR A SECONDARY PROCEDURE TO REMOVE THE BALLOON. THE BALLOON WAS FOUND IN THE LARYNGEAL MASK AIRWAY (LMA) AND WAS REMOVED SUCCESSFULLY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS COMPLAINT IS #1 OF 2 DEVICES, FOR THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040170 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BALLOON EXHIBITED A LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968602 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657538 ↗
• MalfunctionJan 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MAJ-1351 WAS TORN AND DEFECTIVE. THE ISSUE WAS FOUND DURING SET UP BEFORE THE ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS TBNA) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287327 ↗
• InjuryNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ENDOBRONCHIAL ULTRASOUND (EBUS), BRONCHOSCOPY PROCEDURE, A BALLOON WAS POSITIONED ON THE END OF THE SCOPE. AT THE END OF THE PROCEDURE, THE BALLOON WAS NOT ON SCOPE, SO THE PATIENT WAS EXTUBATED. PATIENT RE-SEDATED AND LARYNGEAL MASK AIRWAY (LMA) WAS USED, AND ENTIRE LUNG FIELD WAS RE-EXAMINED. NO BALLOON WAS ABLE TO BE RETRIEVED. FOLLOW-UP HAS BEEN CONDUCTED AND PENDING ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654083 ↗
• InjuryNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ENDOBRONCHIAL ULTRASOUND (EBUS), BRONCHOSCOPY PROCEDURE, A BALLOON WAS POSITIONED ON THE END OF THE SCOPE. AT THE END OF THE PROCEDURE, THE BALLOON WAS NOT ON SCOPE, SO THE PATIENT WAS EXTUBATED. PATIENT RE-SEDATED AND LARYNGEAL MASK AIRWAY (LMA) WAS USED, AND ENTIRE LUNG FIELD WAS RE-EXAMINED. NO BALLOON WAS ABLE TO BE RETRIEVED. FOLLOW-UP HAS BEEN CONDUCTED AND PENDING ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654049 ↗
• MalfunctionOct 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON HAD TINY HOLES IN IT. THE ISSUE WAS FOUND DURING A BRONCHOSCOPY ENDOBRONCHIAL ULTRASOUND PROCEDURE, DURING WHICH THE BALLOONS WERE PLACED AT THE END OF THE BRONCHOSCOPE. THE ISSUE IMPACTED THE DURATION OF THE PROCEDURE; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383418 ↗
• MalfunctionOct 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOONS WHICH WERE PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383059 ↗
• MalfunctionOct 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLONS PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING A BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382956 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOONS PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING A BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375104 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOONS PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING A BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20373536 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE BALLOON PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372238 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WHICH WERE PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371738 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE BALLOON PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371708 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE BALLOON PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371213 ↗
• MalfunctionOct 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON THAT WAS AT THE END OF THE SCOPE HAD TINY HOLES IN THEM. THIS IS THE SECOND OF TWELVE BALLOONS WITH THIS ISSUE. THE ISSUE OCCURRED DURING A BRONCHOSCOPY WITH (ENDOBRONCHIAL ULTRASOUND) EBUS PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371208 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOONS PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING A BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369752 ↗
• MalfunctionSep 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLONS PLACED AT THE END OF THE BRONCHOSCOPE HAD TINY HOLES IN THEM. THE ISSUE OCCURRED DURING A BRONCHOSCOPY-EBUS (ENDOBRONCHIAL ULTRASOUND) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321586 ↗
• MalfunctionAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON WAS RUPTURED OUT OF THE BOX. THE EVENT OCCURRED IN THE MIDDLE OF A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS). THERE WAS AN UNQUANTIFIED AMOUNT OF DELAY TO SEARCH FOR A BALLOON. THE INTENDED PROCEDURE WAS COMPLETED, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988927 ↗
• InjuryJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOSCOPIC BRONCHIAL ULTRASOUND (EBUS) LINEAR FINE NEEDLE ASPIRATION (FNA), THE SCOPE CHANNEL WAS CLOGGED CAUSING AN OBSTRUCTION. THE CLINICIAN WAS UNABLE TO PASS AN INSTRUMENT THROUGH THE CHANNEL AND THE BALLOON FAILED, STATING WHEN LAUNCHING THE BALLOON, IT SLIPPED OFF THE SCOPE. THE INITIAL PASS OF THE NEEDLE WAS FINE, HOWEVER AFTER SEVERAL PASSES, THE NEEDLE GOT STUCK AND WOULD NOT PASS. THERE WAS NO INJURY TO THE PATIENT. WHILE THERE WAS A DELAY, THE TIME IS UNKNOWN. THE INTENDED PROCEDURE WAS NOT COMPLETE. IT WAS ABORTED AND THE PATIENT WILL BE RESCHEDULED. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733806 ↗
• InjuryJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOSCOPIC BRONCHIAL ULTRASOUND (EBUS) LINEAR FINE NEEDLE ASPIRATION (FNA), THE SCOPE CHANNEL WAS CLOGGED CAUSING AN OBSTRUCTION. THE CLINICIAN WAS UNABLE TO PASS AN INSTRUMENT THROUGH THE CHANNEL AND THE BALLOON FAILED, STATING WHEN LAUNCHING THE BALLOON, IT SLIPPED OFF THE SCOPE. THE INITIAL PASS OF THE NEEDLE WAS FINE, HOWEVER AFTER SEVERAL PASSES, THE NEEDLE GOT STUCK AND WOULD NOT PASS. THERE WAS NO INJURY TO THE PATIENT. WHILE THERE WAS A DELAY, THE TIME IS UNKNOWN. THE INTENDED PROCEDURE WAS NOT COMPLETE. IT WAS ABORTED AND THE PATIENT WILL BE RESCHEDULED. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733665 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON HAD A RUPTURE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND THERE WAS AN APPROXIMATE 5 MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610253 ↗
• MalfunctionJun 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE BALLOON WAS TORN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNDISCLOSED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580595 ↗