Cope G48180Recalls & 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
Quick summary
This Cook Medical Cope nephroureterostomy stent is a soft tube used to drain urine from the kidney. The 31 reports mostly describe the blue stiffener inside the catheter sticking or breaking apart, so it cannot be pulled out and the procedure has to be restarted with a new set; fluid or blood leaking and complete blockage are also mentioned. There were 14 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002481800), received between Feb 10, 2017 and Sep 19, 2025 — classified as 14 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (12 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 Remove12
- Fluid/Blood Leak8
- Material Separation7
- Complete Blockage2
- Connection Problem2
- Fitting Problem2
- Obstruction of Flow2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available14
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient5
- Pain3
- Hemorrhage/Blood Loss/Bleeding2
- Nausea2
- No Patient Involvement2
- Fungal Infection1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Material Separation; 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 23099872 ↗InjuryJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
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 18606983 ↗MalfunctionNov 2, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE FROM THE CATHETER INCLUDED IN THE ULTRATHANE COPE NEPHROURETEROSTOMY SET. ON THE BACK TABLE, THE DRAIN AND STIFFENER WERE FLUSHED AND ASSEMBLED. THE ASSEMBLY WAS WIPED DOWN. IT WAS THEN FOUND THAT THE STIFFENER HAD BECOME STUCK IN THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PRODUCT MALFUNCTION ADDED 10 TO 15 MINUTES TO THE PROCEDURE TIME. THIS OCCURRED TWICE WITH TWO DEVICES FROM THE SAME LOT. BOTH CATHETERS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2023. DURING THE PRELIMINARY DEVICE FAILURE ANALYSIS, IT WAS FOUND THAT BOTH DEVICES EXHIBITED SIGNS OF DIFFICULT REMOVAL. ONE OF THE STIFFENERS WAS RETURNED WITH THE HUB SEPARATED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18061711 ↗MalfunctionNov 2, 2023Difficult 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18061702 ↗MalfunctionOct 10, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER ON 17OCT2023. IT WAS FOUND DURING THE PRELIMINARY DEVICE FAILURE ANALYSIS THAT THE FLEXIBLE STIFFENER HAD ELONGATED AND SEPARATED, WITH A PORTION REMAINING IN THE CATHETER LUMEN. THE CATHETER SHAFT REMAINED INTACT. IN ADDITIONAL INFORMATION RECEIVED ON 18OCT2023, IT WAS CONFIRMED THAT ONLY DIFFICULT REMOVAL OF THE STIFFENER WAS EXPERIENCED. THERE WAS NO DIFFICULTY ADVANCING THE STIFFENER INTO THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17907119 ↗InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN ADDITIONAL INFORMATION RECEIVED ON 25OCT2023, IT WAS REPORTED THAT THE PATIENT WAS MOST LIKELY RECEIVING ANTIBIOTICS PRIOR TO THE DISCOVERY OF THE FUNGAL INFECTION, BUT IT WAS NOT CERTAIN. THE PATIENT WAS NOT IMMUNOCOMPROMISED; HOWEVER, THE PATIENT WAS A POORLY CONTROLLED DIABETIC. THE THOUGHT IS THE UNCONTROLLED DIABETES MAY HAVE CONTRIBUTED TO THE YEAST INFECTION. THE PATIENT ALSO HAD AN ILEAL CONDUIT, AND PER THE PHYSICIAN, THE YEAST INFECTION MAY HAVE COME FROM THAT AS WELL. WHEN THE INFECTION WAS DISCOVERED, THE PATIENT HAD A PERIPHERAL IV. THE PATIENT HAD BEEN HOSPITALIZED FOR 24 HOURS PRIOR TO PLACEMENT OF THE COOK DEVICE.
Patient problems: Fungal Infection; Sepsis
MAUDE report 17701319 ↗MalfunctionMay 5, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE STIFFENER IN AN ULTRATHANE COPE NEPHROURETERECTOMY SET WAS DIFFICULT TO REMOVE. AFTER THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT KIDNEY, THE USER WAS UNABLE TO REMOVE THE STIFFENER FROM THE CATHETER. THE ENTIRE DEVICE WAS THEN REMOVED AND THE PROCEDURE STARTED OVER. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14288960 ↗MalfunctionJan 5, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENER IN AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE DURING THE PROCEDURE. AS THE USER WAS ATTEMPTING TO PLACE THE CATHETER IN THE PATIENT, THE DEVICE WAS FLUSHED BUT THE STIFFENER WAS "STICKING TO THE CATHETER" AND COULD NOT BE REMOVED. AS A RESULT, THE DEVICE WAS REMOVED AND A NEW SET WAS PLACED TO COMPLETE THE PROCEDURE. 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 13170019 ↗MalfunctionDec 22, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETERECTOMY SET FOR A NEPHROURETERECTOMY STENT PLACEMENT. DURING THE PROCEDURE, THE STIFFENER COULD NOT BE REMOVED. THE DEVICE WAS REMOVED AND ANOTHER SIMILAR DEVICE WAS PLACED 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 11061424 ↗InjuryNov 11, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET IN THE BLADDER URETER TO THE KIDNEY. ONCE THE CATHETER WAS ADVANCED TO THE BLADDER, THE STIFFENER WAS DIFFICULT TO REMOVE. WHILE ATTEMPTING TO REMOVE THE STIFFENER, THE "END CAP BROKE OFF". A SECOND DEVICE WAS USED AND EXPERIENCED THE SAME FAILURE. THE PATIENT EXPERIENCED NAUSEA, BLEEDING AND PAIN DURING THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE FIRST DEVICE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND DEVICE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Nausea; Pain
MAUDE report 10825083 ↗InjuryNov 11, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET IN THE BLADDER URETER TO THE KIDNEY. ONCE THE CATHETER WAS ADVANCED TO THE BLADDER, THE STIFFENER WAS DIFFICULT TO REMOVE. WHILE ATTEMPTING TO REMOVE THE STIFFENER, THE "END CAP BROKE OFF". A SECOND DEVICE WAS USED AND EXPERIENCED THE SAME FAILURE. THE PATIENT WAS REPORTEDLY "UNSTABLE" AND EXPERIENCED NAUSEA, BLEEDING AND PAIN DURING THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE FIRST DEVICE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND DEVICE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Nausea; Pain
MAUDE report 10824974 ↗MalfunctionAug 28, 2020Difficult 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 Known Impact Or Consequence To Patient
MAUDE report 10466053 ↗MalfunctionAug 28, 2020Difficult 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 Known Impact Or Consequence To Patient
MAUDE report 10465765 ↗InjuryAug 25, 2020Obstruction 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 10452077 ↗InjuryFeb 14, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED A MALE PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETERECTOMY SET PLACED FOR A BILATERAL NEPHROURETERECTOMY CATHETER EXCHANGE ON (B)(6) 2019. ON (B)(6) 2020, THE OPERATOR REPORTED THAT THE STENT WAS "BLOCKING" AND WAS REMOVED FROM THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Code Available; Pain
MAUDE report 9714182 ↗InjuryFeb 13, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED A MALE PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET PLACED FOR A BILATERAL NEPHROURETERECTOMY CATHETER EXCHANGE ON (B)(6) 2019. ON (B)(6) 2020, THE OPERATOR REPORTED THAT THE STENT WAS "BLOCKING" AND WAS REMOVED FROM THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 9707085 ↗InjuryDec 24, 2019Leak/Splash; Material Separation; Leak/Splash; Material Separation
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 9516348 ↗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 9426726 ↗MalfunctionMay 31, 2019Fluid/Blood Leak; Fluid/Blood Leak
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 8658573 ↗MalfunctionDec 31, 2018Fluid/Blood Leak; Fluid/Blood Leak
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206102 ↗MalfunctionDec 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
MANUFACTURER BENCH TESTING WAS PERFORMED FOR UNUSED DEVICES RETURNED AGAINST MEDWATCH REPORT #1820334-2018-03288. DURING TESTING, TWO ULTRATHANE COPE NEPHROURETERECTOMY STENTS WERE FOUND TO LEAK. THESE LEAKAGES ARE RECORDED UNDER THIS MEDWATCH REPORT. THE DEVICES WERE RETURNED UNUSED AND DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8170559 ↗InjuryNov 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY STENT WAS PLACED IN THE BLADDER FOR A URINARY DRAINAGE PROCEDURE. AFTER 2-3 WEEKS, THE PATIENT RETURNED TO THE FACILITY AND THE DEVICE WAS FOUND TO BE LEAKING AT THE HUB OF THE CATHETER. THE DRAIN WAS REPLACED WITH ANOTHER DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Code Available
MAUDE report 8066576 ↗InjuryNov 5, 2018Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 8039138 ↗InjuryNov 5, 2018Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 8039108 ↗InjuryOct 22, 2018Fluid/Blood Leak; Fluid/Blood Leak
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7991779 ↗
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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