Flex-X / IMAGE 1 SRecalls & reported problems across all models
Karl Storz GmbH & Co. KG · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Flex-X / IMAGE 1 S model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 2
We found 4 models of Flex-X / IMAGE 1 S by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 3, 2026 — classified as 6 injuries, 20 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (9 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 / IMAGE 1 S 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 3 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 3 of these models · Recall details · FDA record ↗
Most reported Flex-X / IMAGE 1 S problems
Device problems
- No Display/Image9
- Optical Problem6
- Insufficient Device Problem Information5
- Device Damaged by Another Device2
- Physical Resistance/Sticking2
- Temperature Problem2
- Circuit Failure1
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Bacterial Infection2
- Insufficient Information2
- Foreign Body In Patient1
- Injury1
- No Consequences Or Impact To Patient1
- Rupture1
Flex-X / IMAGE 1 S models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flex-X / IMAGE 1 S 11278VSUUreteroscope and accessories, flexible/rigid2 recalls2 reports
- Flex-X / IMAGE 1 S 11278VSUAUreteroscope and accessories, flexible/rigid2 recalls2 reports
- Flex-X / IMAGE 1 S 11278VSAUreteroscope and accessories, flexible/rigid2 recalls0 reports
- Flex-X / IMAGE 1 S 11278VSUreteroscope and accessories, flexible/rigid22 reports
Recent Flex-X / IMAGE 1 S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595607 ↗MalfunctionSep 2, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571550 ↗MalfunctionAug 13, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235154 ↗MalfunctionJul 2, 2026No Display/Image
IT WAS REPORTED THAT THE FLEXIBLE URETEROSCOPE WOULD NOT CONNECT TO THE VIDEO STACK DURING PROCEDURE. AN IMAGE WAS DISPLAYED FOR APPROXIMATELY 10-15 SECONDS BEFORE INTERMITTENTLY SHUTTING OFF. THE SURGEON ATTEMPTED TO USE THE URETEROSCOPE AGAIN, AT WHICH POINT THE IMAGE REMAINED STABLE AND THE DEVICE FUNCTIONED WITHOUT INTERRUPTION. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT ANY FURTHER ISSUES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696406 ↗MalfunctionMay 27, 2026Output Problem
IT WAS REPORTED THAT "NOT PRODUCING IMAGE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304752 ↗MalfunctionApr 29, 2026No Display/Image
IT WAS REPORTED THAT "LEAKY DISTAL RUBBER, NO IMAGE, NO LIGHT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035848 ↗InjuryMar 5, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL A FEW DAYS AFTER THE PROCEDURE DUE TO DISCOMFORT. BLOOD AND URINE CULTURES SUBSEQUENTLY TESTED POSITIVE FOR BURKHOLDERIA CEPACIA. THE PATIENT REMAINS HOSPITALIZED. HIS CLINICAL CONDITION HAS IMPROVED. HOWEVER, INPATIENT MANAGEMENT IS ONGOING, AND ANTIBIOTIC THERAPY CONTINUES. SINCE THE PATIENT GOT INFECTED AND FURTHER HOSPITALIZATION/MEDICATION IS NECESSARY, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: Bacterial Infection
MAUDE report 24527354 ↗InjuryMar 5, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL A FEW DAYS AFTER THE PROCEDURE DUE TO DISCOMFORT. BLOOD AND URINE CULTURES SUBSEQUENTLY TESTED POSITIVE FOR BURKHOLDERIA CEPACIA. THE PATIENT REMAINS HOSPITALIZED. HIS CLINICAL CONDITION HAS IMPROVED. HOWEVER, INPATIENT MANAGEMENT IS ONGOING, AND ANTIBIOTIC THERAPY CONTINUES. SINCE THE PATIENT GOT INFECTED AND FURTHER HOSPITALIZATION/MEDICATION IS NECESSARY, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: Bacterial Infection
MAUDE report 24527353 ↗MalfunctionMar 5, 2026No Display/Image
IT WAS REPORTED THAT NO IMAGE. LIGHT IS FLASHING OR DISAPPEARING. BUMP AT SHEATH AT 32 CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519309 ↗MalfunctionMar 5, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT LEAKY, IMAGE INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519307 ↗MalfunctionMar 4, 2026No Display/Image; Optical Problem
IT WAS REPORTED THAT "NO IMAGE, DISTAL RUBBER COVER IS LEAKY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24514164 ↗MalfunctionJan 7, 2026No Display/Image; Temperature Problem
IT WAS REPORTED THAT LEAKY WORKING CHANNEL, NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991564 ↗MalfunctionJan 5, 2026No Display/Image; Mechanical Jam
THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT "THE DISTAL RUBBER COVER IS LEAKY, NO IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23970551 ↗MalfunctionDec 29, 2025Temperature Problem; Insufficient Device Problem Information; Temperature Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE SCOPE STOPPED WORKING MID CASE. THE SURGEON BELIEVES THIS IS BECAUSE OF THE INCORRECT DEFLECTION MECHANISM. THE CASE HAD TO BE ABANDONED AS THEY DID NOT HAVE A SPARE SCOPE.
Patient problems: Insufficient Information
MAUDE report 23917743 ↗MalfunctionNov 24, 2025No Display/Image; Residue After Decontamination; No Display/Image; Residue After Decontamination
IT WAS REPORTED THAT THE IMAGES WAS NOT SHOWN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633427 ↗
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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