Cope G48173Recalls & 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
- 17
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002481732), received between May 2, 2018 and Sep 26, 2023 — classified as 6 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (8 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.
Most reported problems
Device problems
- Difficult to Remove8
- Difficult to Advance5
- Leak/Splash5
- Stretched4
- Material Separation3
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Known Impact Or Consequence To Patient8
- No Code Available7
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
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 17818528 ↗MalfunctionDec 8, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
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 15946120 ↗MalfunctionJul 9, 2021Device 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 12144197 ↗InjuryDec 6, 2019Obstruction of Flow; Obstruction of Flow
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 9430224 ↗MalfunctionAug 21, 2019Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8916630 ↗MalfunctionAug 21, 2019Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8916599 ↗MalfunctionAug 21, 2019Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance
NO NEW PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 21AUG2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8916598 ↗MalfunctionAug 21, 2019Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance
IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS SELECTED FOR USE IN AN UNKNOWN PATIENT FOR A NEPHROURETEROSTOMY EXCHANGE PROCEDURE. AS REPORTED, DIFFICULTY WAS EXPERIENCED WHILE ADVANCING THE STIFFENING CANNULA, BUT IT WAS ABLE TO BE PLACED. DIFFICULTY WAS AGAIN EXPERIENCED WHILE REMOVING THE STIFFENER. AS STATED BY THE INITIAL REPORTER, "(THE) STIFFENER STRETCHES UPON INTENDED REMOVAL BUT ULTIMATELY THEY GET IT OUT WITHOUT A BREAKAGE OCCURRING." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8916547 ↗MalfunctionJun 24, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8726388 ↗InjuryJun 18, 2019Fluid/Blood Leak; Leak/Splash; Material Separation; Fluid/Blood Leak; Leak/Splash; Material Separation
SEE H10.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 8707379 ↗MalfunctionJun 13, 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 8695101 ↗InjuryMar 29, 2019Difficult to Remove; Difficult to Remove
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 8464475 ↗MalfunctionOct 15, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN THE PATIENT FOR NEPHROURETERAL DRAINAGE ON AN UNSPECIFIED DATE. IMMEDIATELY UPON PLACEMENT, LEAKAGE WAS DISCOVERED AT THE HUB. THE DRAIN WAS REMOVED AND REPLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION INCLUDING PATIENT INFORMATION. HOWEVER, NONE HAS BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7965010 ↗InjuryMay 18, 2018Leak/Splash; Leak/Splash
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7525700 ↗InjuryMay 18, 2018Leak/Splash; Leak/Splash
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7525641 ↗MalfunctionMay 4, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY SET WAS LEAKING AT THE HUB. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7486135 ↗InjuryMay 2, 2018Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT RETURNED AFTER TWO WEEKS AS THE HUB ON THE EXTERNAL PORTION OF THE ULTRATHANE COPE NEPHROURETEROSTOMY CATHETER HAD FALLEN OFF. THE CATHETER WAS REPLACED WITH ANOTHER PRODUCT WITH NO HARM TO THE PATIENT.
Patient problems: No Code Available
MAUDE report 7480815 ↗
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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