Tuflex 271641Recalls & reported problems
SOMATEX Medical Technologies GmbH · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250195611574), received between Jan 26, 2021 and Jan 29, 2021 — classified as 2 malfunctions.
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
- Device Damaged by Another Device1
- Material Fragmentation1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2021Break
DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE MARKING WIRE TUFLEX WAS TAPPED WITH A CAUTERY DEVICE (BOVIE) AND IT SPLINTERED.
Patient problems: Insufficient Information
MAUDE report 11250305 ↗MalfunctionJan 26, 2021Material Fragmentation; Device Damaged by Another Device
DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE MARKING WIRE TUFLEX WAS TAPPED WITH A CAUTERY DEVICE (BOVIE) AND IT SPLINTERED.
Patient problems: Insufficient Information
MAUDE report 11228616 ↗
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- Kopans G02554Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 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 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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