Flexor G46168Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002461680), received between Oct 27, 2017 and Jan 2, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2020Crack; Crack

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY, THE OUTER SHEATH OF A FLEXOR URETERAL ACCESS SHEATH CRACKED AND CAUSED THE URETERAL MUCOSA TO BLEED. THE QUANTITY OF BLOOD LOST WAS UNSPECIFIED. THE URETERAL BLEEDING RESULTED SURGICAL VISION LOSS. THE SURGERY WAS SUSPENDED UNTIL A ANOTHER URETERAL SHEATH WAS OBTAINED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND EVENT. AT THIS TIME, NOT ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blood Loss

  MAUDE report 9538502 ↗
• MalfunctionJul 23, 2019Unsealed Device Packaging; Unsealed Device Packaging

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 23JUL2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816235 ↗
• MalfunctionJul 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 20AUG2019.

  Patient problems: No Patient Involvement

  MAUDE report 8812985 ↗
• MalfunctionNov 13, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, THE USER OPENED THE PACKAGE OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS AND USED WATER TO ACTIVE THE HYDROPHILIC COATING, BUT FOUND OUT THE THERE WAS WHITE EMULSIONS LIKE MATTER COMING OFF FROM THE SHEATH. THE USER TESTED THE SHEATH WITH THEIR HAND AND FELT RESISTANCE ON THE SURFACE OF THE SHEATH. THE USER SUSPECTED THE HYDROPHILIC COATING IS ABSENT FROM THE SHEATH. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065211 ↗
• MalfunctionAug 7, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE PHYSICIAN WAS USING THE FLEXOR URETERAL ACCESS SHEATH WITH THE SCOPE, AND THE INNER ¿LINER¿ FROM THE OUTSIDE SHEATH PEELED AWAY. CASE WAS COMPLETED AS NORMAL. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW UP. THE SHEATH WAS TAKEN OUT OF THE PATIENT AND THE STENT WAS PLACED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757486 ↗
• MalfunctionOct 27, 2017Material Discolored; Material Discolored

  THE DISTRIBUTOR REPORTED THAT PRIOR TO USE, THE USER FACILITY OBSERVED A WHITE STAIN AT THE DISTAL END OF THE FLEXOR URETERAL ACCESS SHEATH. THIS DEVICE WAS NOT USED. THERE WAS NO CONTACT WITH THE PATIENT. AS REPORTED, THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983508 ↗