Kopans G02900Recalls & 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 00827002029002), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Perforation1
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Migration; Migration
IT WAS REPORTED A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS PLACED IN A FEMALE PATIENT UNDER ULTRASOUND FOR LOCALIZATION OF A NODULE AT THE UNION OF THE EXTERNAL QUADRANTS OF THE RIGHT BREAST. IT WAS REPORTED THE "HARPOON" MIGRATED INTO THE PLEURAL SPACE AND PERFORATED THE LUNG, CAUSING A COMPLETE RIGHT PNEUMOTHORAX. THE PATIENT UNDERWENT THORACIC SURGERY FOR ABLATION ON (B)(6) 2019. THE HARPOON WAS RECOVERED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Perforation; Pneumothorax
MAUDE report 9771277 ↗
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 G03507Cook 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.
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