Flexor G46167Recalls & reported problems
Cook Incorporated · Flexor, Ureteral Access Sheath with AQ, Hydrophilic Coating · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002461673), received between Feb 11, 2015 and Jan 7, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Delamination” (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
- Delamination1
- Device Contamination with Chemical or Other Material1
- Material Separation1
- Peeled/Delaminated1
Patient problems
- Foreign body, removal of1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Peeled/Delaminated
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 23990602 ↗MalfunctionApr 23, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE USER RECEIVED THE FLEXOR URETERAL ACCESS SHEATH AND DILATORS WITH A PARTICLE INSIDE IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7451913 ↗InjuryFeb 11, 2015Material Separation; Delamination
WHILE PREFORMING A DUAL APPROACH PCNL, (PERCUTANEOUS NEPHROLITHOTOMY, WITH URETEROSCOPY), A PIECE OF THE COATING SHEARED OFF. THE PHYSICIAN USED GRASPING FORCEPS TO REMOVE THE PIECE. NO HARM TO THE PT AND NO ADD'L PROCEDURES OR INTERVENTION WERE REQUIRED DUE TO THIS OCCURRENCE.
Patient problems: Foreign body, removal of
MAUDE report 4527431 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.