Kopans G02850Recalls & 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 00827002028500), received between Dec 7, 2017 and Dec 7, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2017Fracture; Fracture
THE INTERNATIONAL CUSTOMER REPORTED THAT ATTEMPTS WERE MADE TO "LOCALISE A LESION" [SIC]; HOWEVER, FOLLOWING A DISCUSSION WITH THE RADIOLOGIST AND THE SURGEON IT WAS DECIDED THAT THE AREA DID NOT NEED TO BE LOCALIZED. THE WIRE OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE REPORTEDLY BROKE IN THE PATIENT'S BREAST "AT THE SHORT HOOK TURN" [SIC]. THIS APPROXIMATELY 9 MM PORTION OF THE HOOK WIRE WAS LEFT IN THE BREAST OF THE PATIENT. THE REMAINING COMPLAINT PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 7097457 ↗
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 G03507Cook 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.
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