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Flexor G19175Recalls & reported problems

Cook Incorporated · Flexor, 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 00827002191754), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 injury.

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

  • Peeled/Delaminated1

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.

  • InjuryJul 18, 2022Peeled/Delaminated; Peeled/Delaminated

    AS REPORTED, DURING THE PROCEDURE AND USING A FLEXOR URETERAL ACCESS SHEATH AND DILATORS THE INNER LINING SLIPPED, AND A PIECE OF THE LINING DETACHED AND ASCENDED INTO THE PATIENT'S RENAL PELVIS. THE PROCEDURE WAS A RETROGRADE INTRARENAL SURGERY (RIRS). COMPLETE REMOVAL OF THE DEVICE WAS REQUIRED. THE PROCEDURE WAS PROLONGED AND TOOK APPROXIMATELY 60 MINUTES. ADDITIONAL PATIENT OUTCOME AND EVENT INFORMATION HAVE BEEN REQUESTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 15041767 ↗

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.