Flexor G19174Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002191747), received between Apr 3, 2025 and Jun 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179537 ↗
• MalfunctionJun 4, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE INNER WALL OF THE DISTAL END OF THE OUTER SHEATH OF A FLEXOR URETERAL ACCESS SHEATH AND DILATOR DETACHED DURING A RETROGRADE INTRARENAL SURGERY (RIRS). THE SHEATH WAS SUCCESSFULLY PLACED. DURING ADVANCE OF THE SOFT ENDOSCOPE, RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE DEVICE WHICH PREVENTED THE ENDOSCOPE FROM ADVANCING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140920 ↗
• MalfunctionApr 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) TO REMOVE A STONE IN THE RIGHT KIDNEY, A PIECE OF PLASTIC WAS FOUND INSIDE THE DILATOR OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS. THE PHYSICIAN DISCONTINUED ITS USE AND COMPLETED THE SURGERY USING THE ACCESS SHEATH ONLY. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762499 ↗