Flexor G34879Recalls & reported problems
Cook Incorporated · Flexor, Ureteral Access Sheath with AQ, Hydrophilic Coating · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002348790), received between Jun 1, 2023 and Apr 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Peeled/Delaminated1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Unsealed Device Packaging
IT WAS REPORTED THE TYVEK PACKAGING OF THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS WAS NOT SEALED. AN IMAGE WAS PROVIDED APPEARED TO SHOW AN UNSEALED PACKAGE. AS REPORTED, NO OTHER ADVERSE EFFECTS WERE REPORTED AS THE EVENT OCCURRED AT THE DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793646 ↗MalfunctionMar 21, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED, A PATIENT UNDERWENT AN URETEROSCOPY PROCEDURE IN WHICH A FLEXOR URETERAL ACCESS SHEATH AND DILATORS WERE USED. THE USER NOTICED WHEN ATTEMPTING TO ENTER THE SHEATH ON THE FIRST ATTEMPT WITH THE URETERAL SCOPE, THAT THE PLASTIC WAS ALREADY FALLING OFF THE CATHETER INNER LINER. THE URETEROSCOPE AND FORCEPS WERE USED TO REMOVE THE PLASTIC. THE SHEATH AND DILATOR WERE NOT SEPARATED DURING ACTIVATION. IT WAS UNKNOWN IF THE HYDROPHILIC COATING WAS ACTIVATED BEFORE USE, WHAT MEDIUM USED, OR HOW LONG IT TOOK TO ACTIVATE THE COATING. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21670666 ↗MalfunctionJun 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041034 ↗
Other endoscopic access overtube, gastroenterology-urology devices
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- Trokamed WA2PS20STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS20LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Trokamed WA2PS18STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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