Kopans G03507Recalls & reported problems
Cook Incorporated · Kopans Breast Lesion Localization Needle · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002035072), received between Aug 3, 2016 and Aug 3, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2016Break; Break
PER (B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT DURING A WIRE LOCALIZED PARTIAL MASTECTOMY ON A (B)(6) FEMALE PATIENT, THE TIP OF A BREAST LESION LOCALIZATION WIRE BROKE INSIDE THE PATIENT'S BREAST. THE PROVIDER WAS UNABLE TO LOCATE AND RETRIEVE THE TIP WHEN PERFORMING SURGERY. THIS WAS DISCLOSED TO THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5842796 ↗
Other NEEDLE, TUMOR LOCALIZATION devices
- Kopans G02587Cook Incorporated · NEEDLE, TUMOR LOCALIZATION5 reports
- Kopans G02586Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Kopans G02554Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Tuflex 271641SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Tuloc 271661SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Kopans G02850Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G02900Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G03795Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
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 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page