Cook G19533Recalls & reported problems
Cook Incorporated · X-Reidy Breast Lesion Localization Needle · Class 1 · Implant
Data updated Oct 13, 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 00827002195332), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
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.
InjuryNov 25, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 9371591 ↗
Other NEEDLE, TUMOR LOCALIZATION devices
- Kopans G02587Cook Incorporated · NEEDLE, TUMOR LOCALIZATION5 reports
- Kopans G02554Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Kopans G02586Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Tuflex 271641SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Tuloc 271661SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Kopans G02900Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G03795Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G02850Cook 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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