BagleyRecalls & reported problems across all models
Gyrus ACMI, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 4 models of Bagley by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 30, 2020 and Sep 2, 2026 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Break” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bagley problems
Device problems
- Break12
- Material Twisted/Bent4
- Overheating of Device3
- Dent in Material2
- Failure to Clean Adequately2
- Sharp Edges2
- Crack1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Patient Involvement2
- Burn(s)1
Bagley models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bagley MR-6LAUreteroscope and accessories, flexible/rigid10 reports
- Bagley MR-6AUreteroscope and accessories, flexible/rigid9 reports
- Bagley REXMR-6AUreteroscope and accessories, flexible/rigid5 reports
- Bagley REXMR-6LAUreteroscope And Accessories, Flexible/Rigid2 reports
Recent Bagley adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573104 ↗MalfunctionJul 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846794 ↗MalfunctionMay 23, 2026Break
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE FLEXIBLE/RIGID URETEROSCOPE AND ITS ACCESSORIES EXHIBITED A DENT ON THE DISTAL END FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264132 ↗MalfunctionMay 22, 2026Overheating of Device
THE URETEROSCOPE AND ACCESSORIES WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF WHEN DISCONNECTING THE TWO PIECES, IT WAS EXTREMELY DIFFICULT TO SEPARATE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BURN FIBERS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262350 ↗MalfunctionApr 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD RED STUFF STUCK IN THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24855672 ↗MalfunctionApr 10, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE OR RIGID, HAD A BURNT LIGHT GUIDE FIBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838814 ↗MalfunctionApr 3, 2026Material Deformation; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE URETEROSCOPE AND ACCESSORIES (FLEXIBLE, RIGID) HAD WHITE FLUID IN THE DISTAL CHANNEL AND A BENT DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781612 ↗MalfunctionApr 1, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID PRESENTED SHARP DENT ON THE DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755471 ↗MalfunctionMar 30, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID EXHIBITED SHARP DENT ON DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735601 ↗MalfunctionJan 8, 2026Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24007505 ↗MalfunctionDec 18, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837474 ↗MalfunctionNov 7, 2025Break; Poor Quality Image; Break; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BLURRY VIEW THROUGH THE SCOPE AND DAMAGE TO THE LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494335 ↗MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A SEVERE BEND AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921609 ↗MalfunctionJul 10, 2025Material Twisted/Bent; Material Twisted/Bent
DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED A BENT OUTER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22474751 ↗MalfunctionSep 16, 2024Break; No Display/Image; Break; No Display/Image
IT WAS REPORTED THE URETEROSCOPE DISTAL TIP WAS DAMAGED AND/OR BROKEN WITH A SHARP EDGE, COULD NOT SEE THE PICTURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233737 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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