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Flexor G30390Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002303904), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    AS REPORTED, INSIDE THE SEALED PACKAGE OF A FLEXOR URETERAL ACCESS SHEATH AND DILATORS THE USERS NOTED A FOREIGN OBJECT DESCRIBED AS A FLAKE OR PAINT CHIP. THE DEVICE WAS NOT OPENED AND DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13280403 ↗

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.