Cope G08687Recalls & reported problems
Cook Incorporated · Cope Mandril Wire Guide Nitinol · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002086876), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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.
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-1829-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Difficult to Remove1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON 07DEC2022, IT WAS REPORTED THAT THE PEEL-AWAY DILATOR WITH INNER DILATOR WAS FROM A 5FR PICC KIT FROM ANOTHER MANUFACTURER. THE WIRE WAS MOST LIKELY MANIPULATED THROUGH A COOK NEEDLE FIRST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915866 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.