Flexor Parallel G34873Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002348738), received between Jul 24, 2018 and Dec 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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.

• MalfunctionDec 16, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE INNER LINER OF THE SHEATH OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS DELAMINATED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. WHEN ADVANCING THE URETEROSCOPE THROUGH THE SHEATH, THE USER OBSERVED THE SURFACE OF THE INNER LINER OF THE SHEATH FRAYING. THE USER ALSO NOTED THE 'INTERNAL COATING' PEELING. THE DEVICE WAS REPLACED WITH A NEW, SIMILAR-LIKE DEVICE TO COMPLETE THE PROCEDURE. 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 23824891 ↗
• MalfunctionJul 1, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  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 19647393 ↗
• MalfunctionJul 21, 2022Separation Failure; Separation Failure

  AS REPORTED, DURING A URETEROSCOPY WITH LASER, THE INNER STYLET OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS SET SPLIT EARLY, AND ANOTHER MANUFACTURER'S WIRE "POPPED OFF". THE DEVICE WAS PLACED VIA RAPID TECHNIQUE AND ADVANCED WITHOUT DIFFICULTY WHEN THE FAILURE OCCURRED. THE RELEASE OF THE WIRE WAS ABRUPT AND OCCURRED BEFORE THE STYLET WAS REMOVED FROM THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073901 ↗
• MalfunctionAug 12, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316966 ↗
• MalfunctionJul 24, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, DURING A URETEROSCOPY PROCEDURE, STRINGY MATERIAL WAS ENTERING THE BLADDER WHEN THE INNER DILATOR OF SHEATH WAS GOING THROUGH LUMEN OF SHEATH AND PROTRUDING FROM END OF SHEATH OF THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS. A NEW ACCESS SHEATH WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE STRINGY MATERIAL FROM INSIDE THE LUMEN OF THE SHEATH WAS COMING OFF AND BEING LEFT IN THE BLADDER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7714045 ↗