BioPince Ultra Full Core Biopsy Instrument 360-2080-03Recalls & reported problems
Argon Medical Devices, Inc. · BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 18ga x 20cm)(Introducer Needle: 16ga x 16.8cm) · Class 2
All models of BioPince Ultra Full Core Biopsy Instrument (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333224050), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K904987); they may or may not involve this specific model.
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
Recalls naming this device
- Jul 2, 2024Class IIOpen, Classified
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
Z-3192-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2025Break; Break
CUSTOMER REPORTED "THE INTRODUCER OF THE BPU BROKE OFF INSIDE THE PATIENT WHEN IT WAS BEING ADVANCED. ENDED UP HAVING A SURGEON REMOVE IT."
Patient problems: Insufficient Information
MAUDE report 22211685 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K904987. One submission often covers many models, so check the product and lot details in each record.
- Z-2427-2020 · Dec 2, 2019 · TerminatedBioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Ins
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- 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 · each recall links to the FDA recall notice
- 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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