SuperCore™ Biopsy Instrument 701218150Recalls & reported problems
Argon Medical Devices, Inc. · SuperCore™ Biopsy Instrument with Co-Axial Introducer Needle · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333005987), received between Nov 8, 2021 and Sep 22, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Detachment of Device or Device Component1
- Nonstandard Device1
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.
MalfunctionSep 22, 2023Break; Break
THE NEEDLE SUPPORT BROKE, CAUSING DAMAGE TO THE PATIENT AND DISSATISFACTION FOR THE PHYSICIAN.
Patient problems: Insufficient Information
MAUDE report 17798309 ↗MalfunctionJan 24, 2022Break
NEEDLE CAME OUT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13334135 ↗MalfunctionNov 8, 2021Nonstandard Device; Detachment of Device or Device Component
1ST PASS: PHYSICIAN PRESSED PLUNGER TO OBTAIN SPECIMEN AND DEVICE HANDLE CAME APART. DID NOT OBTAIN SPECIMEN. PATIENT STARTED BLEEDING, NODULE COULD NOT BE SEEN DUE TO BLEEDING AND UNABLE TO PULL ANOTHER DEVICE TO MAKE A 2ND PASS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12776170 ↗
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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