Skip to content

Flexor Parallel G56431Recalls & reported problems

Cook Incorporated · Flexor, Parallel Rapid Release Ureteral Access Sheath with AQ, Hydrophilic Coating · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002564312), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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

Device problems

  • Material Separation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 12, 2021Material Separation; Material Separation

    AS REPORTED, DURING A STONE EXTRACTION PROCEDURE, A METAL SUBSTANCE CAME OUT OF THE LUMEN OF THE SHEATH IN A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS SET. THE DEVICE WAS USED FOR INSERTION OF ANOTHER MANUFACTURER'S SCOPE, A LASER, AND A COOK NCIRCLE BASKET. WHEN USING THE BASKET FOR STONE EXTRACTION, TWO METAL SUBSTANCES WERE OBSERVED AMONG THE STONES. THESE SUBSTANCES WERE REMOVED FROM THE PATIENT USING THE BASKET. THE PROCEDURE WAS COMPLETED WITH THE FLEXOR SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: Foreign Body In Patient

    MAUDE report 12803675 ↗

Other endoscopic access overtube, gastroenterology-urology devices

All endoscopic access overtube, gastroenterology-urology devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.