Flexor G19168Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002191686), received between Jul 11, 2017 and Feb 22, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363148 ↗
• InjuryFeb 21, 2018Material Separation; Material Separation

  EVENT INFORMATION RECEIVED VIA SUS VOLUNTARY EVENT FORM RECEIVED FROM HHS/FDA. REFERENCE: MW5074563. IT WAS REPORTED DURING USE OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS, A PIECE OF THE SHEATH BROKE OFF INSIDE THE PATIENT. THE DOCTOR WAS ABLE TO RETRIEVE IT. NO ADVERSE EFFECT TO THE PATIENT HAS BEEN REPORTED. THE FACILITY HAS BEEN CONTACTED TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. AT THE TIME OF THIS REPORT THERE HAS BEEN NO NEW INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286181 ↗
• Jan 12, 2018Break

  PIECE OF SHEATH BROKE OFF INSIDE OF PATIENT. MD ABLE TO RETRIEVE.

  Patient problems: No Information

  MAUDE report 7193696 ↗
• MalfunctionDec 28, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THAT THE ACCESS SHEATH WAS USED TO GAIN ACCESS INTO THE URETER FOR DILATION. THE SCOPE WAS THEN PLACED INSIDE THE ACCESS SHEATH AND A PIECE OF PLASTIC FROM INSIDE THE ACCESS SHEATH CAME LOOSE. THE ACCESS SHEATH WAS REMOVED WITH THE PLASTIC PIECE AND ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO KNOWN ADVERSE EVENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151714 ↗
• MalfunctionJul 11, 2017Defective Component; Material Integrity Problem; Defective Component; Material Integrity Problem

  IT WAS REPORTED THAT WHILE PERFORMING AN URETEROSCOPY PROCEDURE, THE PHYSICIAN USED A FLEXOR URETERAL ACCESS SHEATH AND DILATORS AND NOTICED THAT THE INSIDE OF THE SHEATH FRAYED. THE SHEATH WAS REMOVED AND A NEW FLEXOR URETERAL ACCESS SHEATH WAS INTRODUCED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE 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 6700136 ↗