Flexor Parallel G56438Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002564381), received between Apr 10, 2018 and Apr 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Coiled” (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.

• MalfunctionApr 1, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ PACKAGE WAS FOUND UNSEALED DURING AN UNSPECIFIED PROCEDURE. UPON OPENING THE PACKAGE, THE SHEATH SLIPPED OUT REPORTEDLY DUE TO A MISSING SEAM. IT WAS NOT USED. A NEW SHEATH WAS OPENED TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFORMATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741766 ↗
• MalfunctionApr 10, 2018Coiled; Device Operates Differently Than Expected

  THE COMPLAINANT REPORTED THAT THE FLEXOR PARALLEL URETERAL ACCESS SHEATH WAS IN POSITION AND WHEN THE DILATOR WAS REMOVED, THE WIRE WAS RELEASED ON THE TIP FOR REMAINING ACCESS IN THE WORKING CHANNEL. THE WIRE WAS CURLED UP SPIRALLY DURING THE PROCEDURE, SO WORKING CHANNEL ACCESS WAS NO LONGER POSSIBLE. IT WAS FURTHER NOTED THAT AN UNIDENTIFIED WIRE WAS UNCOILED. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7419335 ↗