BiWire G46141Recalls & reported problems
Cook Incorporated · BiWire Nitinol Core Wire Guide With Hydrophilic Coating Standard Shaft · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002461413), received between Mar 18, 2021 and Sep 13, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3 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.
Reports received per month
Most reported problems
Device problems
- Material Separation3
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; 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 20212883 ↗MalfunctionJun 23, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED 02AUG2021. THE SEPARATED SEGMENT OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT OUTCOME WAS "GOOD".
Patient problems: Foreign Body In Patient
MAUDE report 12053344 ↗MalfunctionMar 18, 2021Material 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 11514835 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.