Flexor Parallel G34872Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002348721), received between Jul 19, 2022 and Feb 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED, THE NURSE WENT TO OPEN THE PACKAGE OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS AND NOTICED THE SEAL WAS OPEN. THE DEVICE WAS FOUND PRIOR TO PATIENT CONTACT. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A PHOTO OF WHAT APPEARS TO SHOW UNSEALED DEVICE PACKAGING WAS ATTACHED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439143 ↗
• MalfunctionJul 19, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATOR PERFORATED A PATIENTS BLADDER. THE USER REPORTED THE TIP OF THE INNER STYLET SHEATH SPLIT EARLY AND THE WIRE CAME OFF. THE USER ALSO REPORTED THAT THE DEVICES WIRE RELEASE FUNCTION IS VERY ABRUPT AND RELEASES BEFORE THE STYLET IS PULLED FROM THE SHEATH FOR PROPER DEPLOYMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 15057441 ↗