CopeRecalls & reported problems across all models
Cook Incorporated · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Cope model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 188
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls
- 2
We found 23 models of Cope by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 188 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2016 and Sep 17, 2026 — classified as 80 injuries, 108 malfunctions.
The most frequently reported specific device problem is “Material Separation” (54 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cope recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1830-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1829-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
Most reported Cope problems
Device problems
- Material Separation54
- Difficult to Remove43
- Unraveled Material27
- Fluid/Blood Leak22
- Detachment of Device or Device Component14
- Leak/Splash14
- Break13
- Difficult to Advance8
Patient problems
- No Code Available52
- No Known Impact Or Consequence To Patient49
- No Clinical Signs, Symptoms or Conditions44
- Foreign Body In Patient23
- No Consequences Or Impact To Patient9
- Device Embedded In Tissue or Plaque8
- Insufficient Information7
- No Information4
Cope models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cope G05183WIRE, GUIDE, CATHETER1 recall41 reports
- Cope G08427WIRE, GUIDE, CATHETER1 recall23 reports
- Cope G05822WIRE, GUIDE, CATHETER1 recall3 reports
- Cope G08687WIRE, GUIDE, CATHETER1 recall1 report
- Cope G09395WIRE, GUIDE, CATHETER1 recall1 report
- Cope G10077WIRE, GUIDE, CATHETER1 recall1 report
- Cope G48180Stent, ureteral31 reports
- Cope G48176Stent, ureteral26 reports
- Cope G48173Stent, ureteral17 reports
- Cope G48166Stent, ureteral9 reports
- Cope G48164Stent, ureteral8 reports
- Cope G05177WIRE, GUIDE, CATHETER7 reports
- Cope G48183Stent, ureteral4 reports
- Cope G48160Stent, ureteral3 reports
- Cope G48168Stent, ureteral3 reports
- Cope G48170Stent, ureteral3 reports
- Cope G04474CATHETER, BILIARY, DIAGNOSTIC1 report
- Cope G05176WIRE, GUIDE, CATHETER1 report
- Cope G08620ACCESSORIES, CATHETER1 report
- Cope G08733WIRE, GUIDE, CATHETER1 report
- Cope G09593WIRE, GUIDE, CATHETER1 report
- Cope G11701Stent, ureteral1 report
- Cope G48162Stent, ureteral1 report
Recent Cope adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 20, 2026Obstruction of Flow
IT WAS REPORTED THAT THE CATHETER FROM A ULTRATHANE COPE NEPHROURETEROSTOMY SET KINKED. THE DEVICE WAS REQUIRED FOR USE A URETERAL STENT AND WAS PLACED IN THE PATIENT'S KIDNEY ON (B)(6) 2026. NINE DAYS LATER, ON (B)(6) 2026, WHEN THE DEVICE WAS BEING REMOVED, A KINK WAS NOTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.. PRELIMINARY ANALYSIS OF THE RETURNED DEVICE ON 12MAR2026 REVEALED INDICATION OF OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649943 ↗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 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF THE DRAINAGE CATHETER FROM AN ULTRATHANE COPE NEPHROURETEROSTOMY SET DETACHED. DURING AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT, THE HUB DETACHED FROM THE COPE NEPHROURETEROSTOMY STENT. HUB DETACHMENT WAS REPORTED TO OCCUR WITH FIVE ADDITIONAL STENTS PRIOR TO PATIENT CONTACT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH AN UNSPECIFIED 8.5 FRENCH SIZED STENT. 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 23927170 ↗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 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 ↗MalfunctionSep 18, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 23086399 ↗MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
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 23041973 ↗MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
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 23041817 ↗MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
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 23041739 ↗MalfunctionAug 6, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON 30JUL2025, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING BOTH INSERTION AND REMOVAL DUE TO ANATOMIC TORTUOSITY. THE SECTION OF THE COPE WIRE THAT SEPARATED AND REMAINED IN THE PATIENT MEASURED 1-2MM (CAPTURED IN REPORT WITH PATIENT IDENTIFIER (B)(6). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AS THE WIRE WITHIN THE NEFF SET WORKED WITHOUT ISSUE. IT WAS CONFIRMED THAT THE PATIENT HAS NOT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADDITIONAL ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730015 ↗MalfunctionAug 6, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON JULY 30, 2025, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING BOTH INSERTION AND REMOVAL DUE TO ANATOMIC TORTUOSITY. THE SECTION OF THE COPE WIRE THAT SEPARATED AND REMAINED IN THE PATIENT MEASURED 1-2MM, CAPTURED IN REPORT WITH PATIENT IDENTIFIER (B)(6). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AS THE WIRE WITHIN THE NEFF SET WORKED WITHOUT ISSUE. IT WAS CONFIRMED THAT THE PATIENT HAS NOT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADDITIONAL ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22729953 ↗MalfunctionAug 6, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON 30JUL2025, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING BOTH INSERTION AND REMOVAL DUE TO ANATOMIC TORTUOSITY. THE SECTION OF THE COPE WIRE THAT SEPARATED AND REMAINED IN THE PATIENT MEASURED 1-2MM (CAPTURED IN REPORT WITH PATIENT IDENTIFIER (B)(4)). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AS THE WIRE WITHIN THE NEFF SET WORKED WITHOUT ISSUE. IT WAS CONFIRMED THAT THE PATIENT HAS NOT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADDITIONAL ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22729726 ↗InjuryMay 30, 2025Fluid/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 22117162 ↗MalfunctionMay 21, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE COPE MANDRIL WIRE GUIDE UNRAVELED. THE GUIDEWIRE FROM A NEWLY OPENED SET WAS INTRODUCED THROUGH A COMPETITOR NEEDLE FOR PERCUTANEOUS LEFT PORTAL VENOUS ACCESS. UPON INSERTION, THE TIP OF THE WIRE APPEARED TO HAVE PARTIALLY DETACHED AND ELONGATED LIKE A STRING. THE WIRE GUIDE WAS REPLACED WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062533 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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