SuperCore™ Biopsy Instrument 701116090Recalls & reported problems
Argon Medical Devices, Inc. · SuperCore™ Biopsy Instrument 16ga x 9cm · Class 2
All models of SuperCore Biopsy Instrument (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333005918), received between Feb 27, 2024 and Nov 23, 2025 — classified as 1 injury, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2025Break; Break
A PHYSICIAN REPORTED THAT HE COLLECTED THE FRAGMENT, WHEN REMOVING THE SAMPLE FROM THE TRIGGER INSIDE THE NEEDLE, IT BROKE AND CAME LOOSE FROM THE NEEDLE. THE NEEDLE WAS CONTAMINATED AND DUE TO THE RISK OF CONTAMINATION, IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23626986 ↗InjuryMay 1, 2025Material Twisted/Bent; Material Twisted/Bent
WHEN USING A BIOPSY NEEDLE TO PERFORM BREAST PUNCTURE ON A PATIENT'S BREAST MASS, IT IS DIFFICULT TO PUNCTURE THE NEEDLE. IT WAS FOUND THAT THE NEEDLE HAS A BENT GROOVE, WHICH POSES A RISK OF DAMAGING THE SURROUNDING TISSUE OF THE MASS. IT IS NECESSARY TO REMOVE THE BIOPSY NEEDLE AGAIN, STRAIGHTEN THE VALVE, AND RE PUNCTURE, WHICH MAY CAUSE THE MASS TISSUE TO OVERFLOW DURING PUNCTURE.
Patient problems: Insufficient Information
MAUDE report 21945313 ↗MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A FACILITY REPORTED THAT DURING A BONE BIOPSY PROCEDURE, THE NEEDLE BECAME TOTALLY DISCONNECTED FROM THE HUB DURING THE ACQUISITION OF A SAMPLE. THIS RESULTED IN A LARGE BLOOD SPRAY COVERING THE PHYSICIAN AND EQUIPMENT. THERE WAS NO PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18793159 ↗
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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