Cope G48170Recalls & reported problems
Cook Incorporated · Cope Nephroureterostomy Stent Ultrathane · Class 2
All models of Cope (23)
Data updated Oct 16, 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 00827002481701), received between Feb 1, 2024 and Oct 30, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE "INNER YELLOW INSERT" HUB BROKE OFF FROM THE "BLUE COMPONENT" OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET DURING AN UNSPECIFIED PROCEDURE ON A 51-YEAR-OLD MALE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON 22OCT2024, AND UPON A REVIEW OF THE PRELIMINARY DFA FINDINGS, IT WAS FOUND THAT THE HUB OF THE FLEXIBLE STIFFENER HAD SEPARATED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569815 ↗MalfunctionMar 29, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE FROM THE DRAINAGE CATHETER. ADDITIONALLY, THE STRING THAT FORMS THE PROXIMAL PIGTAIL BECAME ATTACHED WHEN PULLED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19005811 ↗MalfunctionFeb 1, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE. THE DEVICE WAS REQUIRED FOR A STENT CHANGE PROCEDURE. AFTER THE CATHETER WAS PLACED IN THE PATIENT, THE STIFFENER COULD NOT BE REMOVED. THE CATHETER WAS THEN REMOVED AND REPLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18623781 ↗
Other Stent, ureteral devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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