Cope G48183Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002481831), received between Aug 26, 2019 and Jun 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 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 Remove3
- Difficult to Advance2
- Crack1
- Detachment of Device or Device Component1
- Material Separation1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19505281 ↗MalfunctionJun 22, 2022Crack; Crack
IT WAS REPORTED A PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET FOR A CATHETER EXCHANGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS CRACKED AT THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SIMILAR DEVICE. 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 14774451 ↗MalfunctionNov 5, 2019Difficult 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 Known Impact Or Consequence To Patient
MAUDE report 9278148 ↗MalfunctionAug 26, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8932519 ↗
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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