Flex-XRecalls & reported problems across all models
Karl Storz GmbH & Co. KG · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Flex-X model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 4
We found 12 models of Flex-X by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and Sep 22, 2026 — classified as 4 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. 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
Flex-X recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 1, 2022Open, Classified
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Z-1070-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Apr 1, 2022Open, Classified
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Z-1069-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Apr 1, 2022Open, Classified
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Z-1068-2022 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- Apr 1, 2022Open, Classified
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Z-1067-2022 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
Most reported Flex-X problems
Device problems
- Display or Visual Feedback Problem2
- Material Protrusion/Extrusion2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Erratic or Intermittent Display1
- Fracture1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Perforation2
- Insufficient Information1
- Laceration(s)1
- No Consequences Or Impact To Patient1
- Rupture1
Flex-X models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flex-X 11278VSUEUreteroscope and accessories, flexible/rigid2 recalls0 reports
- Flex-X 11278VSEUreteroscope and accessories, flexible/rigid2 recalls0 reports
- Flex-X 11278AU1Ureteroscope and accessories, flexible/rigid1 recall5 reports
- Flex-X 11278VUUreteroscope and accessories, flexible/rigid1 recall1 report
- Flex-X 11278AC1Ureteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278ACU1Ureteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278VUreteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278AC2Ureteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278A2Ureteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278VAUreteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278VUAUreteroscope and accessories, flexible/rigid1 recall0 reports
- Flex-X 11278A1Ureteroscope and accessories, flexible/rigid6 reports
Recent Flex-X adverse event reports
The 12 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860222 ↗MalfunctionApr 3, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT OPTICAL SYSTEM DAMAGED FOR NO APPARENT REASON, CAUSING BLURRED VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779629 ↗MalfunctionMar 13, 2026Crack
IT WAS REPORTED: "THE DEFLECTION IS DEFECTIVE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591615 ↗MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING URETEROSCOPY, THE ANGLED GUIDEWIRE APPEARED TO BREAK WHILE BEING MANIPULATED OVER THE GUIDEWIRE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23890606 ↗MalfunctionDec 22, 2025Erratic or Intermittent Display; Fracture; Erratic or Intermittent Display; Fracture
ACCORDING TO THE INFORMATION RECEIVED, IMAGE DROPOUTS DURING PROCEDURE OBSERVED AND A LEAKAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865585 ↗MalfunctionFeb 7, 2025Optical Obstruction; Physical Resistance/Sticking; Optical Obstruction; Physical Resistance/Sticking
IT WAS REPORTED THAT: THERE'S AIR LEAKAGE HAPPENING, AND THE WORKING CHANNEL IS CLOGGED. THE DEFLECTION IS EITHER INSUFFICIENT. NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21334637 ↗InjuryMay 9, 2022Material Fragmentation; Improper or Incorrect Procedure or Method; Material Integrity Problem; Material Fragmentation; Improper or Incorrect Procedure or Method; Material Integrity Problem
PER COPY OF MDR #MW5106633 RECEIVED VIA MAIL FROM THE FDA: WHILE USING FLEXIBLE URETEROSCOPE DURING A URETEROSCOPY DOCTOR VISUALIZED A FOREIGN OBJECT. IT WAS RETRIEVED AND WAS BLUE IN COLOR AND OBSERVED BY STAFF. IT WAS DETERMINED TO BE PART OF SCOPE. NO PATIENT HARM DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14339104 ↗InjuryMar 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
PER COPY OF MDR #MW506891 RECEIVED VIA EMAIL FROM THE FDA: WHILE USING FLEXIBLE URETEROSCOPE THE URETER WAS TORN AND A URETERAL STENT HAS TO BE PLACED UNTIL TEAR HEALED.
Patient problems: Rupture
MAUDE report 13824598 ↗MalfunctionFeb 6, 2019Material Separation; Material Separation
DURING A URETEROSCOPY PROCEDURE THE DISTAL WRAP OF THE SCOPE CAME APART INSIDE THE PATIENT'S BLADDER. THE BROKEN PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8313098 ↗InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, DURING A STONE REMOVAL PROCEDURE WITH A FLEX-XC VIDEO URETEROSCOPE, THE PATIENT'S URETER WAS TORN.
Patient problems: Laceration(s)
MAUDE report 7708326 ↗InjuryJul 21, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion
ALLEGEDLY, THE DOCTOR REPORTED THAT SHE WAS PERFORMING A URETEROSCOPY W/KIDNEY STONE REMOVAL ON A PATIENT AND WHEN SHE REMOVED THE SCOPE FROM THE PATIENT THE URETER WAS PUNCTURED AND TORN. DOCTOR WAS 3/4 OF THE WAY INTO THE CASE AND HAD TO ABORT THE CASE EARLY, SINCE PATIENT'S URETER WAS INJURED AND HER VIEW WAS OBSTRUCTED AS A RESULT OF THE PROTRUDED AND BUBBLED SHEATHING AT DISTAL END OF THE SCOPE. THEY WERE UNABLE TO PLACE A STENT AT THAT TIME. DOCTOR CONFIRMED THE INJURY ON (B)(6) 2017; WALL OF THE URETER WAS PUNCTURED AND TORN. THEY HAD TO INSERT A PERCUTANEOUS NEPHROSTOMY TUBE OR CATHETER INSIDE PATIENT'S KIDNEY TO DRAIN URINE AND INSERT A PERCUTANEOUS ANTIGRADE STENT. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2017 AND SCHEDULED TO COME BACK FOR A FOLLOW-UP ON (B)(6) 2017 TO HAVE NEPHROSTOMY TUBE REMOVED. DOCTOR WILL BE MONITORING PATIENT'S PROGRESS.
Patient problems: Perforation
MAUDE report 6734291 ↗MalfunctionApr 7, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion
ALLEGEDLY, THE HOSPITAL STATED THAT DURING A URETEROSCOPY PROCEDURE THE DOCTOR COULD NOT REMOVE SCOPE FROM PATIENT. THEY CUT THE SHAFT FROM THE HANDLE TO REMOVE SCOPE. THE PATIENT SUSTAINED A SMALL PERFORATION TO THE URETER AND A STENT WAS USED FOR AN EXTENDED PERIOD OF TIME. THE DOCTOR USED ANOTHER URETEROSCOPE TO COMPLETE PROCEDURE. THE DOCTOR STATES PATIENT CONDITION IS GOOD.
Patient problems: Perforation
MAUDE report 6474278 ↗
Other Karl Storz GmbH & Co. KG products
All Karl Storz GmbH & Co. KG devices →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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