SINGLE USE BIOPSY VALVE MAJ-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 14953170152433), received between Dec 7, 2018 and Sep 29, 2026 — classified as 108 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Break” (127 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 29, 2026Class IIOpen, Classified

   Potential for rubber fragment detachment during use.

   Z-1488-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 221 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  The customer reported during a bronchoscopy, while applying anesthetic via a syringe, a fragment of the device was found to have detached. The fragment entered the syringe, so there was no drop inside the body. The procedure was completed after replacement with the similar product. There were no reports of health hazard due to this event and no delay in reporting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927050 ↗
• InjurySep 28, 2026Fracture; Detachment of Device or Device Component

  The customer reported that during a diagnostic bronchoalveolar lavage and ultrasound examination, while the patient was under sedation, the rubber portion of the single use biopsy valve was chipped in a half-moon shape. The dropped-off portion was searched for, but its whereabouts are unknown. The customer also confirmed that an attempt was made to retrieve the broken portion, but no further details were provided. The procedure was completed with a similar device. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923202 ↗
• InjurySep 28, 2026Detachment of Device or Device Component

  The customer reported that a fragment of the Single-Use Biopsy Valve detached and fell into the bronchus during a diagnostic Endobronchial Ultrasound with a Guide Sheath (EBUS-GS) procedure for specimen collection. The event occurred while the patient was under sedation and the device was in use. The detached fragment was retrieved using biopsy forceps, and all components were reported to have been retrieved. The procedure was completed using an Olympus backup device. No serious injury or adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919682 ↗
• InjurySep 22, 2026Detachment of Device or Device Component

  It was reported that during an unknown procedure, a piece of the biopsy valve rubber fell off into the patient¿s body but was retrieved immediately. It is unknown which part of the body the rubber piece fell into and what tool was used for retrieval. The procedure was completed after switching to another biopsy valve. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856327 ↗
• InjurySep 16, 2026Break; Detachment of Device or Device Component

  It was reported that during a diagnostic bronchoscopy, after the biopsy forceps were inserted for the first time to remove a mucus plug, the single use biopsy valve broke and a fragment dropped into the bronchus. The fragment was grasped and retrieved with the forceps. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791333 ↗
• MalfunctionSep 15, 2026Residue After Decontamination; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779345 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50721702 ↗
• MalfunctionSep 9, 2026Break; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699106 ↗
• MalfunctionAug 28, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506990 ↗
• MalfunctionAug 25, 2026Device Reprocessing Problem; Gas/Air Leak; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441694 ↗
• MalfunctionAug 21, 2026Gas/Air Leak; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376600 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229589 ↗
• MalfunctionAug 12, 2026Gas/Air Leak; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221417 ↗
• InjuryAug 4, 2026Break; Detachment of Device or Device Component

  It was reported during a diagnostic Endobronchial Ultrasound with Guide Sheath (EBUS-GS) procedure there was a black foreign material found inside the patient body. It was through to be a damaged part of the single use biopsy valve. It was suctioned and retrieved. The procedure was prolonged less than thirty minutes. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134036 ↗
• InjuryApr 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL BIOPSY PROCEDURE, A PART OF THE SINGLE USE BIOPSY VALVE WENT MISSING INSIDE THE PATIENT WHEN THE DEVICE WAS REMOVED FROM THE SCOPE. THE PART WAS RETRIEVED FROM PATIENT WITH NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049233 ↗
• MalfunctionApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LID PART OF THE SINGLE USE BIOPSY VALVE BROKE AND FELL OFF DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048746 ↗
• MalfunctionApr 17, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910268 ↗
• InjuryApr 14, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN UNKNOWN DIAGNOSTIC PROCEDURE THAT THE SINGLE USE BIOPSY VALVE FELL APART AND RIPPED, AND PART OF THE DEVICE ENDED UP IN THE PATIENTS LUNG THAT WAS RETRIEVED VIA SUCTION WITH THE SCOPE, DURING A MODERATE SEDATION WITH FENTANYL AND VERSED, WITH NO REPORTS OF FURTHER PATIENT HARM. THERE WERE NO UNPLANNED DIAGNOSTIC IMAGING TO LOCATE THE DEVICE AS THEY WERE ABLE TO MAINTAIN VISUALIZATION WITH THE SCOPE THE ENTIRE TIME AND THEN VISUALIZED THE PIECE IN THE SUCTION CANISTER. THERE WERE NO FURTHER TROUBLESHOOTING PERFORMED. THE REMAINDER OF THE PROCEDURE WAS ABORTED. NO FURTHER REPORT OF PATIENT HARM AFTER DEVICE RETRIEVAL OR REASON FOR ABORTING PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED TO BE "AT BASELINE". THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879643 ↗
• MalfunctionApr 6, 2026Break; Detachment of Device or Device Component

  THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795702 ↗
• InjuryMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE, WHILE USING A SYRINGE FOR LOCAL ANESTHESIA A RUBBER PIECE OF THE SINGLE USE BIOPSY VALVE FELL INTO THE BRONCHUS. AFTER THE FALL, A NEW SINGLE USE BIOPSY VALVE WAS USED, BUT THE SAME EVENT OCCURRED AGAIN. BOTH FALLEN PIECES WERE RETRIEVED. THE TOOLS AND METHODS USED FOR THE RETRIEVAL WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT SINGLE USE BIOPSY VALVE. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717265 ↗
• InjuryMar 30, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716416 ↗
• InjuryMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, WHILE INSERTING THE GUIDE SHEATH A PIECE OF THE SINGLE USE BIOPSY VALVE FELL OFF INTO THE BRONCHUS. THE FALLEN PIECE WAS RETRIEVED. THE TOOL AND METHOD USED FOR RETRIEVAL WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706349 ↗
• InjuryMar 25, 2026Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC EBUS-GS (ENDOBRONCHIAL ULTRASONOGRAPHY USING A GUIDE SHEATH), AN ABNORMAL NOISE STARTED IMMEDIATELY AFTER THE SYRINGE WAS INSERTED FOR ANESTHESIA. SUBSEQUENTLY, A RUBBER FRAGMENT BELIEVED TO BE PART OF THE SINGLE USE BIOPSY VALVE WAS FOUND IN THE PATIENT¿S BRONCHUS. THE FRAGMENT WAS RETRIEVED WITH BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688769 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SINGLE USE BIOPSY VALVE FELL OFF. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590616 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE SINGLE USE BIOPSY VALVE HAD THE INTERNAL SEAL RING DAMAGED WHILE ANESTHETIC WAS BEING ADMINISTERED VIA SYRINGE. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY. THERE WAS NO DELAY REPORTED AND IT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENTS¿ HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580331 ↗