Dormia EXN734Recalls & reported problems
Coloplast A/S · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03600040955529), received between Apr 4, 2025 and Apr 10, 2026 — classified as 2 injuries, 3 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close3
- Fracture2
- Material Separation2
- Material Deformation1
- Misassembly by Users1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Difficult to Open or Close; Material Deformation; Misassembly by Users
ACCORDING TO THE AVAILABLE INFORMATION, DURING AN URETEROSCOPY FOR A KIDNEY STONE, THE DORMIA DEVICE IN QUESTION WAS NOT FUNCTIONING PROPERLY. THE SMALL BASKET AT THE TIP OF THE DORMIA WAS BROKEN AND NO LONGER HAD ITS USUAL SHAPE, WHICH PREVENTED THE SURGEON FROM PROPERLY GRASPING THE STONE. A NEW DEVICE WAS PROVIDED. THIS RESULTED IN WASTED TIME AND AN EXTENDED PROCEDURE DURATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839375 ↗MalfunctionDec 11, 2025Fracture; Difficult to Open or Close; Fracture; Difficult to Open or Close
ACCORDING TO THE AVAILABLE INFORMATION THE BLUE SHEATH DETACHED FROM THE BASKET AND WOULD NOT OPEN OR CLOSE WHEN IT HAD A STONE IN THE BASKET. THE BASKET WAS REMOVED ALONGSIDE THE SCOPE, AND ONCE OUT THE PATIENT IT WAS NOT OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23779423 ↗InjuryJun 4, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, WHEN USED IN ENDOSCOPY, THE BASKET BECAME DETACHED FROM THE FIBER. THE DEVICE WAS REMOVED WITH FORCEPS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140438 ↗MalfunctionJun 2, 2025Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close
ACCORDING TO THE AVAILABLE INFORMATION, THE STONE BASKET SPLIT INTO 2 PARTS AND COULD NO LONGER BE USED. ANOTHER BASKET HAD TO BE OPENED. NO HARM TO USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122876 ↗MalfunctionApr 4, 2025Material Separation; Material Separation
ACCORDING TO THE AVAILABLE INFORMATION, THE BASKET BROKE INSIDE THE PATIENT AND WAS LEFT INSIDE. THE OUTER BLUE COVER CAME LOOSE. NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775528 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.