Cope G48164Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002481640), received between Jan 24, 2018 and Sep 17, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50809515 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER INCLUDED IN AN ULTRATHANE COPE NEPHROURETEROSTOMY SET EXPERIENCED MAC-LOC HUB SEPARATION PRIOR TO USE IN A NEPHROSTOMY STENT PLACEMENT PROCEDURE FOR AN UNKNOWN PATIENT. AS A RESULT OF THIS ISSUE, THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED COMPETITOR'S 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 24370233 ↗
• MalfunctionApr 18, 2023Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE DURING THE PLACEMENT OF A NEPHROURETEROSTOMY STENT IN THE KIDNEY OF AN UNKNOWN PATIENT. DUE TO THE DIFFICULT REMOVAL, THE BLUE FLEXIBLE STIFFENER AND SUTURE STRING BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765550 ↗
• MalfunctionAug 8, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE FROM THE CATHETER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET. THE GUIDEWIRE, STIFFENER, AND CATHETER WERE ALL FLUSHED PRIOR TO INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND SET, THOUGH WIRE AND STIFFENER WERE ALSO DIFFICULT TO REMOVE AND HAD TO BE REMOVED TOGETHER. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING DEVICE AND PATIENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Intraoperative Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188199 ↗
• InjuryJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET. THE DEVICE WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR DEVICE HUB SEPARATION. THE DEVICE WAS REMOVED AND REPLACED WITH A LIKE DEVICE WITHOUT INCIDENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953620 ↗
• MalfunctionOct 7, 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 Consequences Or Impact To Patient

  MAUDE report 10643720 ↗
• InjuryAug 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7823299 ↗
• MalfunctionJan 24, 2018Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT, WHILE IN USE IN A PATIENT, THE ULTRATHANE COPE NEPHROURETEROSTOMY STENT COULD NOT BE SEPARATED FROM THE BLUE STIFFENER INCLUDED IN THE SET. THE PRODUCT WAS REMOVED FORM THE PATIENT, AND A NEW ONE WAS OPENED AND UTILIZED TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO ADVERSE EVENTS OR ADDITIONAL PROCEDURES REPORTED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216939 ↗