Cope G05822Recalls & reported problems
Cook Incorporated · Cope Mandril Wire Guide Stainless Steel · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002058224), received between Aug 6, 2025 and Aug 6, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (3 reports).
1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Unraveled Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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