Flexor G34880Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002348806), received between May 10, 2017 and May 14, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Peeled/Delaminated

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, THE INSIDE OF THE SHEATH OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS SHEATH PEELED OFF. IT WAS REPORTED, THERE WERE "INSIDE PIECES OF THE SHEATH" THAT SEPARATED INSIDE OF THE PATIENT AND THE PIECES WERE FLUSHED OUT AND ALSO REMOVED WITH A GRABBER. NO PART OF THE SHEATH WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHEATH. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175800 ↗
• MalfunctionJan 28, 2026Peeled/Delaminated

  AS REPORTED, DURING URETEROSCOPY PROCEDURE IN THE KIDNEY, THE SHEATH OF 'FLEXOR URETERAL ACCESS SHEATH AND DILATORS' SHEARED INTERNALLY. THIS ISSUE OCCURRED DURING PASSING OF THE COOK'S BASKET. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE. THE FRAGMENTS REMAINED IN THE URETERAL ACCESS SHEATH (UAS), AND NOTHING HAD TO BE REMOVED FROM THE PATIENT. THE STONE WAS 1CM IN SIZE AND WAS LASERED INTO SMALLER PIECES/FRAGMENTS. AN UNSPECIFIED MANUFACTURER'S 200 MICROMETER FIBER WAS USED DURING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202878 ↗
• MalfunctionNov 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED A MALE PATIENT OF UNDISCLOSED AGE UNDERWENT A FLEXIBLE URETEROSCOPY-LITHOTRIPSY PROCEDURE IN WHICH THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS WERE USED. WHILE REMOVING STONE FRAGMENTS, THE SURGEON NOTICED THAT FRAGMENTS OF THE INNER PART OF THE SHEATH WERE COMING LOOSE. THE SURGEON REMOVED THE FRAGMENTS AND THE SHEATH AT THE END OF THE PROCEDURE, REPLACING IT WITH ANOTHER. 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 23451124 ↗
• MalfunctionSep 23, 2025Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE USER FOUND THAT WHILE USING THE EXTRACTION PROBE INSIDE THE SHEATH OF A FLEXOR URETERAL ACCESS SHEATH AND DILATORS, THE SHEATH BEGAN TO RELEASE STRANDS FROM THE INTERIOR SURFACE. THIS OCCURRED WHEN THE STONE SPICULES CAME INTO FRICTION WITH THE INSIDE OF THE SHEATH. THE USER DETECTED THE ISSUE AFTER REMOVING STONES "ABOUT THREE TIMES" DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED ALTHOUGH IS UNKNOWN HOW IT WAS COMPLETED. UNSPECIFIED FLEXIBLE OPTICS, URETERAL SHEATH, GUIDE WIRE, AND EXTRACTION TUBE WERE ALSO USED DURING THE PROCEDURE. THE USER EXPRESSED CONCERN ABOUT CONTINUING THE PROCEDURE DUE TO SAFETY CONCERNS, FEARING THAT THE LOOSE THREADS MIGHT BECOME EMBEDDED IN THE STONE, WHICH COULD COMPLICATE REMOVAL AND POTENTIALLY POSE A RISK TO THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125677 ↗
• MalfunctionJul 31, 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 22676568 ↗
• MalfunctionApr 23, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE; THE PHYSICIAN OBSERVED THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS WAS FALLING OR DETACHING (THE INNER LINING WAS SEPARATING FROM THE SHEATH). 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 21896145 ↗
• MalfunctionApr 21, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS, WAS USED FOR A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE AND AFTER THE URINARY STONES WERE CRUSHED WITH BASKET FORCEPS; DURING THE COLLECTION OF THE FRAGMENTS A THREAD-LIKE FOREIGN OBJECT WAS FOUND IN THE URINARY TRACT. IT IS BELIEVED THAT THE FOREIGN OBJECT MAY BE A PART OF THE LUMEN OF THE PRODUCT (ABRASION/SCRAPING). THE DEVICE WAS RETRIEVED, AND THE USE OF THE DEVICE WAS DISCONTINUED. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AN IMAGE OF WHAT APPEARS TO SHOW FOREIGN OBJECT WAS PROVIDED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. 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 21877664 ↗
• MalfunctionApr 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, WHEN A FLEXOR URETERAL ACCESS SHEATH AND DILATORS PACKAGE WAS OPENED, THERE WAS A HAIR ON THE DEVICE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116479 ↗
• MalfunctionOct 4, 2022Flaked; Flaked

  AS REPORTED, THE "MATERIAL FIBER" OF THE SHEATH OF A FLEXOR URETERAL ACCESS SHEATH AND DILATORS SET WAS EXPOSED, INTERFERING WITH THE VISION OF AN UNSPECIFIED URETEROSCOPE. 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 15540211 ↗
• MalfunctionNov 30, 2020Material Frayed; Material Frayed

  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; No Consequences Or Impact To Patient

  MAUDE report 10918807 ↗
• MalfunctionMay 10, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING THE URETEROSCOPY WITH LASER AND STONE EXTRACTION PROCEDURE ON A PATIENT. WHILE EXTRACTING STONE FRAGMENTS THROUGH FLEXOR URETERAL ACCESS SHEATH WITH THE NGAGE NITINOL STONE EXTRACTOR BASKET, THE SURGEON NOTICED STRIPS OF A PLASTIC TYPE MATERIAL THAT WERE COLLECTING IN THE SHEATH. THE SHEATH WAS THEN REMOVED ALONG WITH THE PLASTIC MATERIAL AND A NEW FLEXOR URETERAL ACCESS SHEATH WAS INTRODUCED. THE PHYSICIAN WAS ABLE TO REMOVE ALL OF THE FRAGMENTS FROM THE END OF THE SHEATH. 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 6556501 ↗