Flex-X / IMAGE 1 S 11278VSRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04048551344408), received between Aug 23, 2023 and Sep 3, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 15, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem

  IT WAS REPORTED THAT THE DEVICE HAS NO PICTURE / NO LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22816349 ↗
• MalfunctionJul 21, 2025Circuit Failure; Optical Problem; Circuit Failure; Optical Problem

  IT WAS REPORTED THAT SCOPE STOPPED WORKING DURING THE PROCEDURE LOST VISION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER, DISPOSABLE SCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554032 ↗
• MalfunctionJul 7, 2025Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  ACCORDING TO THE INFORMATION RECEIVED, A BLOCKED INSTRUMENT CHANNEL WAS OBSERVED. THE CUSTOMER HAS CONFIRMED THAT THIS WAS REPORTED IN ERROR AND THAT NO PATIENT INCIDENT OCCURRED. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419051 ↗
• MalfunctionJun 2, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE DISTAL RUBBER COVER IS LEAKY AND CCD/CMQS: NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124846 ↗
• MalfunctionJun 2, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE WORKING CHANNEL IS LEAKING AND THERE IS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124734 ↗
• MalfunctionMar 31, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT NO IMAGE./ALWAYS./PRESSURE COMPENSATION CAP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733931 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT THE "LASER FIBRE WENT THROUGH DURING PROCEDURE IN THE THEATRE. LEAK. FAULTY ANGULATION". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON JULY 9, 2024 WE WERE INFORMED THAT THE PROCEDURE WAS ABORTED BECAUSE OF THE REPORTED MALFUNCTION. CONSEQUENTLY, THE SURGERY WAS RESCHEDULED. SINCE THE SURGERY WAS ABORTED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795229 ↗
• InjuryJul 22, 2024Device Damaged by Another Device; Insufficient Device Problem Information; Device Damaged by Another Device; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT THE "LASER FIBRE WENT THROUGH DURING PROCEDURE IN THE THEATRE. LEAK. FAULTY ANGULATION". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON (B)(6) 2024 WE WERE INFORMED THAT THE PROCEDURE WAS ABORTED BECAUSE OF THE REPORTED MALFUNCTION. CONSEQUENTLY, THE SURGERY WAS RESCHEDULED. SINCE THE SURGERY WAS ABORTED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795023 ↗
• InjuryAug 23, 2023Material Invagination; Ejection Problem; Material Invagination; Ejection Problem

  THE PATIENT HAS PREVIOUSLY HAD URETERIC STONES AND PREVIOUS SURGERIES. PYELOGRAM PERFORMED AT THE START OF THE CASE, IDENTIFIED PATIENT HAD A STRICTURE IN THE RIGHT URETER. (B)(6) 23, FLEX XC WAS BEING USED FOR A PRIMARY URETEROSCOPY TO LASER A 7MM MID URETERIC STONE LOCATED IN THE RIGHT SIDE URETER. NO ACCESS SHEATH WAS USED ONLY A GUIDE WIRE ALONGSIDE SCOPE. AFTER THE STONE WAS LASERED, THE SURGEON WENT TO REMOVE THE SCOPE, HOWEVER, WAS UNABLE TO BE PULLED OUT. MEDICATION WAS PROVIDED TO THE PATIENT TO RELAX THE URETER TO ASSIST IN DILATING ENOUGH TO REMOVE THE SCOPE; HOWEVER, THE INTERVENTION WAS NOT SUCCESSFUL. A DECISION WAS MADE BY THE CLINICAL TEAM TO LEAVE THE SCOPE TO THE PATIENT. THE SCOPE WAS THEN SUCCESSFULLY REMOVED ON (B)(6) 23. THE SCOPE SHEATH ON THE DISTAL END OF THE SCOPE HAD BUNCHED TOGETHER (SEE IMAGES ATTACHED). THE PATIENT WAS ADMITTED TO ICU AND IS REPORTED FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17605209 ↗