Dormia EXN934Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03600040955581), received between Apr 18, 2025 and Apr 2, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break

  ACCORDING TO THE AVAILABLE INFORMATION, PRIOR TO USE, ONE WIRE OF THE BASKET BECAME DETACHED AT THE BEGINNING OF THE PROCEDURE. NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769878 ↗
• InjuryMar 24, 2026Difficult to Open or Close

  ACCORDING TO THE AVAILABLE INFORMATION, ATTEMPTED TO RETRIEVE THE STONE USING THE PRODUCT, BUT THE BASKET'S RANGE OF MOTION ON THE OPERATING HANDLE SIDE WAS TOO LIMITED. THIS PREVENTED THE TIP FROM FULLY RETRACTING DURING STONE RETRIEVAL, NECESSITATING DISCONTINUATION OF USE. ANOTHER UNIT FROM THE SAME LOT WAS USED, BUT THE SAME MALFUNCTION OCCURRED, PREVENTING STONE RETRIEVAL AND REQUIRING DISCONTINUATION OF THE PROCEDURE. THE BASKET IS NOT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673578 ↗
• MalfunctionMar 4, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION AFTER OPENING THE PRODUCT, THE BASE OF THE BASKET BROKE DURING OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508365 ↗
• MalfunctionFeb 11, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION WHILE USING THE DEVICE, THE BASKET PORTION BROKE AFTER OPENING AND CLOSING IT 4 TO 5 TIMES, SO THEY STOPPED USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315313 ↗
• MalfunctionJan 13, 2026Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION THE TIP OF THE PRODUCT WAS BROKEN OFF BEFORE USE, RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055535 ↗
• InjurySep 17, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION AFTER CRUSHING THE CALCULUS, THE BASKET HOLDING THE CALCULUS BROKE WHEN PULLING THE DORMIA OUT OF THE RETRACE. THE BROKEN BASKET WAS RECOVERED USING FORCEPS. A LASER WAS USED, BUT SINCE IT WAS NOT USED AT THE SAME TIME, INTERFERENCE IS UNLIKELY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT'S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075440 ↗
• MalfunctionAug 6, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE AVAILABLE INFORMATION DURING THE EXTRACTION OF KIDNEY STONES, THE DEVICE FUNCTIONED PROPERLY DURING ALMOST THE ENTIRE PROCEDURE, THEN BEGAN TO CLOSE LESS AND LESS (NO RESISTANCE IN THE HANDLE, BUT THE BASKET RETRACTED LESS AND LESS INTO THE SHEATH). AFTER MANIPULATION BY THE USER (DISASSEMBLY OF THE HANDLE, REPOSITIONING OF THE BASKET, AND REASSEMBLY OF THE HANDLE), THE DEVICE WAS RECALIBRATED TO RESTORE ITS INITIAL FUNCTIONALITY. THEN THE PREVIOUSLY DESCRIBED PHENOMENON QUICKLY RECURRED (AFTER 3¿4 ACTIVATIONS), UNTIL THE BASKET NO LONGER RETRACTED INTO THE SHEATH AT ALL AND REMAINED OPEN. THE WIRE BROKE AND WAS RELATED TO A LASER SHOT. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730903 ↗
• MalfunctionAug 6, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION THE WIRE BROKE DURING USE. THE SAME PRODUCT WAS USED FROM THEIR INVENTORY AS A REPLACEMENT. USER SUFFERED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730636 ↗
• MalfunctionApr 18, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE AVAILABLE INFORMATION, THE DISTAL WELD CAME UNDONE DURING USE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868152 ↗