Cope G48176Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002481763), received between May 12, 2017 and Oct 15, 2025 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Difficult 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 23285446 ↗
• MalfunctionSep 8, 2023Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION WAS PROVIDED ON 26SEP2023. THE PATIENT HAD A URETER OBSTRUCTION AND URETER RECANALISATION INTERVENTION WAS PERFORMED. THE DEVICE WAS PLACED PERCUTANEOUS INTO THE URETER TO PERFORM INT. EXT URETERAL DRAINAGE. THE COATING OF THE DEVICE WAS ACTIVATED FOR 2 MINUTES BY A SALINE SYRINGE. THE DEVICE WAS ONLY IN PLACE FOR A COUPLE OF SECONDS BEFORE REMOVAL. AFTER THE SECOND REMOVAL OF THE DEVICE, THE SAME TYPE OF COOK DEVICE BUT OF A DIFFERENT LENGTH, 26CM, WAS USED TO COMPLETED THE PROCEDURE SUCCESSFULLY. IT WAS NOTED THE PATIENT HAD NORMAL ANATOMY AND THE USER WORE LATEX GLOVES. NO PHOTOS, VIDEOS, OR PATHOLOGY REPORTS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712664 ↗
• InjuryFeb 22, 2023Material 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 16419606 ↗
• MalfunctionJan 11, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IN ADDITIONAL INFORMATION RECEIVED 27JAN2023, IT WAS REPORTED THAT THE DEVICE WAS REQUIRED FOR A NU (NEPHROURETEROSTOMY) PLACEMENT. ALSO, IT WAS CLARIFIED AS TO WHAT WAS MEANT BY BROKE, MEANING THE "CAP" OR HUB WAS CRACKED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE, AND IT WAS VERIFIED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139421 ↗
• InjuryOct 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER HUB IN AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS LEAKING AFTER INSERTION. IT IS UNKNOWN AT THIS TIME HOW LONG THE DEVICE WAS IN PLACE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE CATHETER AND REPLACE WITH A NEW DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589719 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT REQUIRED A ULTRATHANE COPE NEPHROURETERECTOMY SET FOR A BILATERAL DRAIN EXCHANGE IN THE KIDNEYS. DURING THE PROCEDURE, THE STIFFENER'S HUB SEPARATED UPON REMOVAL. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME LOT, AND THE SUTURE BROKE UPON LOCKING THE PIGTAIL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED BY PLACING TWO SIMILAR DEVICES FOR BILATERAL DRAINAGE. 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 14886897 ↗
• MalfunctionJul 30, 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 10344494 ↗
• MalfunctionMar 16, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET FOR A NEPHROURETERAL TUBE EXCHANGE. THE OPERATOR REPORTED, ONCE THE CATHETER WAS PLACED IN THE PATIENT, THE BLUE STIFFENER WAS UNABLE TO BE REMOVED FROM THE CATHETER. THE ENTIRE DEVICE HAD TO BE REMOVED FROM PATIENT AND ANOTHER SIMILAR 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 9835052 ↗
• InjuryFeb 21, 2020Material Separation; Material Separation

  IT WAS REPORTED A MALE PATIENT REQUIRED THE USE OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET FOR A BILATERAL DRAIN TUBE EXCHANGE PROCEDURE. THE OPERATOR REPORTED PLACING THE NEW DRAIN UTILIZING A DIRECT STICK TECHNIQUE. AFTER PLACEMENT , THE DEVICE WAS REPORTED TO BE SECURED USING A "STATLOCK" DEVICE. APPROXIMATELY TEN MINUTES AFTER THE PROCEDURE WAS COMPLETED THE TECH WAS CONNECTING THE DEVICE TO DRAINAGE WHEN THE HUB SEPARATED FROM THE CATHETER. THE TECH "CALLED THE PHYSICIAN BACK TO THE PROCEDURE AREA AND HE VISUALLY INSPECTED THE DRAIN AND THEY WERE NOT ABLE TO REATTACH THE HUB ONTO THE DRAIN OF THE CATHETER." THE DEVICE WAS REMOVED AND ANOTHER SIMILAR DEVICE WAS SUCCESSFULLY PLACED IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9741776 ↗
• MalfunctionMay 3, 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 Consequences Or Impact To Patient

  MAUDE report 8578360 ↗
• MalfunctionMay 2, 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 Known Impact Or Consequence To Patient

  MAUDE report 8574162 ↗
• MalfunctionMay 2, 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 Known Impact Or Consequence To Patient

  MAUDE report 8574161 ↗
• MalfunctionApr 8, 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 Code Available

  MAUDE report 8491582 ↗
• MalfunctionMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE STENT FROM AN ULTRATHANE COPE NEPHROURETERECTOMY SET LEAKED AFTER PLACEMENT. THE LEAK OCCURRED AT THE LOCATION THE HUB JOINS THE CATHETER. A NEW, SIMILAR STENT 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 Consequences Or Impact To Patient

  MAUDE report 8413015 ↗
• InjuryDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN THE PATIENT'S KIDNEY FOR A NEPHROURETERECTOMY PROCEDURE. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT NOTICED LEAKAGE AT THE HUB. THE DEVICE WAS EXCHANGED A WEEK AFTER THE INITIAL PLACEMENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 8141827 ↗
• MalfunctionOct 29, 2018Connection Problem; Connection Problem

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT (THROUGH THE BACK AND INTO THE KIDNEY DOWN TO THE BLADDER) WAS SELECTED TO REPLACE A NEPHROURETERAL CATHETER ONE MONTH AFTER THE INITIAL CATHETER PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FOUND TO BE LEAKING AT THE CONNECTION BETWEEN THE CATHETER AND THE HUB. AS A RESULT, THE STENT WAS REMOVED AND REPLACED WITH AN IDENTICAL STENT (SAME LOT) WHICH ALSO LEAKED. ANOTHER MANUFACTURER'S DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. AS REPORTED, ALTHOUGH THE PROCEDURE TIME WAS PROLONGED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015442 ↗
• InjurySep 18, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN THE PATIENT FOR NEPHROURETERAL DRAINAGE. THE DEVICE WAS IN PLACE FOR APPROXIMATELY 2 WEEKS BEFORE LEAKAGE WAS CONFIRMED BY THE FACILITY. THE DEVICE WAS THEN REPLACED WITH ANOTHER LIKE DRAIN. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7886632 ↗
• InjurySep 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN THE PATIENT FOR A NEPHROURETERECTOMY PROCEDURE. THE NEXT DAY, THE STENT WAS CONFIRMED TO LEAK FROM THE AREA THE STENT ATTACHES TO THE HUB. THIS LEAKAGE IS DOCUMENTED UNDER MEDWATCH 1820334-2018-02638. THE STENT WAS THEN REPLACED WITH ANOTHER STENT THAT ALSO LEAKED FROM THE SAME AREA. THIS REPORT DOCUMENTS THE SECOND LEAKAGE. ANOTHER STENT OF A DIFFERENT SIZE WAS USED TO COMPLETE THE ENTIRE PLACEMENT SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7881919 ↗
• InjurySep 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY STENT WAS PLACED IN THE PATIENT FOR A NEPHROURETEROSTOMY PROCEDURE. THE NEXT DAY, THE STENT WAS CONFIRMED TO LEAK FROM THE AREA THE STENT ATTACHES TO THE HUB. THIS REPORT DOCUMENTS THE INITIAL LEAKAGE. THE STENT WAS THEN REPLACED WITH ANOTHER STENT THAT ALSO LEAKED FROM THE SAME AREA. MEDWATCH 1820334-2018-02694 DOCUMENTS THIS SECOND LEAK. ANOTHER STENT OF A DIFFERENT SIZE WAS USED TO COMPLETE THE ENTIRE PLACEMENT SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7881893 ↗
• InjuryJun 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FOLLOWING A SUCCESSFUL PERCUTANEOUS NEPHROURETERECTOMY TUBE PLACEMENT IN THE KIDNEY'S, THE PATIENT EXPERIENCED COMPLICATIONS APPROXIMATELY ONE HOUR INTO POST-OP. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND WAS SAID TO HAVE MALIGNANT URETERAL STENOSIS. A LOSS OF URINE FROM THE RIGHT NEPHROURETERECTOMY BEGAN AND CONTINUED THROUGH THE NIGHT. THE PHYSICIAN CHECKED THE DEVICE THE FOLLOWING DAY AND DETERMINED THE MAC LOCK WAS NOT FUNCTIONING AS INTENDED. THE DEVICE WAS REMOVED AND ANOTHER LIKE DEVICE WAS USED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7633272 ↗
• MalfunctionMay 18, 2018Leak/Splash; Leak/Splash

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7525040 ↗
• MalfunctionFeb 19, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT, SHORTLY FOLLOWING PLACEMENT OF THE DEVICE DURING A NEPHROURETEROSTOMY, THE HUB OF THE ULTRATHANE COPE NEPHROURETEROSTOMY SET SEPARATED FROM THE CATHETER PORTION OFF THE DEVICE. THE REPORTED ISSUE OCCURRED TWICE DURING THE PROCEDURE. (SEE RELATED EMDR# 1820334-2018-0366). THE DEVICE HAD TO BE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE PRODUCT PROBLEM, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280834 ↗
• MalfunctionFeb 19, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT, SHORTLY FOLLOWING PLACEMENT OF THE DEVICE DURING A NEPHROURETEROSTOMY, THE HUB OF THE ULTRATHANE COPE NEPHROURETEROSTOMY SET SEPARATED FROM THE CATHETER PORTION OFF THE DEVICE. THE REPORTED ISSUE OCCURRED TWICE DURING THE PROCEDURE. (SEE RELATED EMDR# 1820334-2018-0368). THE DEVICE HAD TO BE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE PRODUCT PROBLEM, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280723 ↗
• MalfunctionJan 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER PORTION OF THE ULTRATHANE COPE NEPHROURETERECTOMY SET WAS LEAKING FROM AROUND THE HUB OF THE DEVICE. THE CUSTOMER CONFIRMED THERE WERE NO PATIENT ADVERSE EVENTS WHICH RESULTED FORM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE ISSUE. THE PROCEDURE BEING PERFORMED WAS A NEPHROURETERAL STENT PLACEMENT, AND THE LEAKAGE REPORTEDLY OCCURRED DURING THE INITIAL PLACEMENT OF THE DEVICE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226752 ↗
• InjuryAug 24, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE HUB OF THE DEVICE SEPARATED. THE DEVICE WAS ORIGINALLY PLACED ON (B)(6) 2017. THE SEPARATION OCCURRED ON (B)(6) 2017, AND IT NECESSITATED THE REMOVAL AND REPLACEMENT OF THE DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816211 ↗