SuperCore™ Biopsy Instrument 701118060Recalls & reported problems
Argon Medical Devices, Inc. · SuperCore™ Biopsy Instrument 18ga x 6cm · Class 2
All models of SuperCore Biopsy Instrument (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333005963), received between Aug 3, 2021 and Aug 17, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- Needle Stick/Puncture1
- Swelling/ Edema1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2023Break; Break
DESCRIBE THE EVENT OR PROBLEM: THE RADIOLOGIST WAS DOING A PROCEDURE ON THE PATIENT'S LEFT SHOULDER. WHEN SHE PULLED THE DEVICE FROM THE PATIENT AFTER TAKING A PASS CONTAINING A SPECIMEN THE DEVICE DISASSEMBLED FALLING APART IN THE RADIOLOGIST HANDS. SHE WAS ALMOST PUNCTURED WITH THE BLADE FROM THE DEVICE. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE WAS HARD TO USE;
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17564607 ↗MalfunctionJul 26, 2023
THE RADIOLOGIST WAS DOING A PROCEDURE ON THE PATIENT'S LEFT SHOULDER. WHEN SHE PULLED THE DEVICE FROM THE PATIENT AFTER TAKING A PASS CONTAINING A SPECIMEN THE DEVICE DISASSEMBLED FALLING APART IN THE RADIOLOGIST HANDS. SHE WAS ALMOST PUNCTURED WITH THE BLADE FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396427 ↗MalfunctionOct 28, 2021Material Separation
MalfunctionOct 28, 2021Break
SPRING POPPED OPEN AS THE NEEDLE WAS PLACED WITHIN THE NECK @ THYROID NODULE.
Patient problems: Insufficient Information
MAUDE report 12712501 ↗MalfunctionAug 3, 2021Break
3 DEVICES FELL APART. DOCTOR WAS STUCK WITH THE NEEDLE WHEN IT BROKE.
Patient problems: Needle Stick/Puncture
MAUDE report 12269647 ↗
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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