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Flexor G19172Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002191723), received between Sep 20, 2019 and Oct 29, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Fluid/Blood Leak1
  • Material Separation1

Patient problems

  • No Code Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryOct 29, 2019Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Code Available

    MAUDE report 9249433 ↗
  • MalfunctionSep 20, 2019Material Separation; Material Separation

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9098597 ↗

Other endoscopic access overtube, gastroenterology-urology devices

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