Pro-Mag™ Biopsy Needle 765014100Recalls & reported problems
Argon Medical Devices, Inc. · Pro-Mag™ Biopsy Needle 14ga x 10cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333006861), received between Jan 17, 2023 and Dec 1, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem1
- Material Twisted/Bent1
- Mechanical Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Material Twisted/Bent; Material Twisted/Bent
DR. (B)(6) PERES MASTOLOGIST REPORTED WHAT HAPPENED DURING THE PATIENT'S BREAST BIOPSY, THE NEEDLE BENT AFTER FIRING THE PRO-MAG PISTOL AND CAUSING ABNORMAL BLEEDING. THE PHYSICIAN WAS SCARED, AS THIS HAD NEVER HAPPENED BEFORE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18253127 ↗InjuryJan 17, 2023Mechanical Problem; Fail-Safe Problem
IT TOOK MORE THAN ONE SHOT TO HARVEST A FRAGMENT. WITH THE LAST PATIENT, THE CUTTING BLADE (WHICH WAS OPEN) CAUSED INJURY TO SMALL VESSELS AND BLEEDING. THIS HAS CAUSED SOME INCONVENIENCE TO MY MEDICAL TEAM. NOTE: THIS IS THE DOCTOR'S SECOND COMPLAINT WITH A DIFFERENT BATCH. PREVIOUS COMPLAINT NO. (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 16187183 ↗
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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