SuperCore™ Biopsy Instrument 701116150Recalls & reported problems
Argon Medical Devices, Inc. · SuperCore™ Biopsy Instrument 16ga x 15cm · Class 2
All models of SuperCore Biopsy Instrument (9)
Data updated Oct 18, 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 00886333005826), received between Sep 10, 2020 and Aug 9, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.
Most reported problems
Device problems
- Material Rupture1
- Material Twisted/Bent1
- Nonstandard Device1
Patient problems
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2022Nonstandard Device; Material Rupture
WHEN PERFORMING BREAST TUMOR PUNCTURE BIOPSY, THE BIOPSY NEEDLE RUPTURED AND INJURED THE FINGERS OF MEDICAL STAFF. IMMEDIATELY REPLACE THE BIOPSY NEEDLE, AND THE MEDICAL STAFF CLEANED AND DISINFECTED THE WOUND.
Patient problems: Needle Stick/Puncture
MAUDE report 15191113 ↗MalfunctionSep 10, 2020Material Twisted/Bent
Other Instrument, Biopsy devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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