Cook G00466Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Safe-T-J, Curved · 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 00827002004665), received between Mar 4, 2021 and Mar 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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-1833-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent1
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.
MalfunctionMar 4, 2021Material Twisted/Bent
ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, ATRIAL FIBRILLATION AND RECENT SHORTNESS OF BREATH. WHILE PREPARING FOR A HEART CATH, THE COOK FIXED CORE WIRE GUIDE WAS BENT UPON TAKING IT OUT OF THE PACKAGE. DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11411926 ↗
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- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.