Skip to content

BioPince™ Ultra Full Core Biopsy Instrument 370-1080-03Recalls & reported problems

Argon Medical Devices, Inc. · BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 16ga x 10cm)(Introducer Needle: 14ga x 6.8cm) · 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
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333224074), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Firing Problem” (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.

Recalls naming this device

  1. 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

  • Firing Problem1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 19, 2023Firing Problem; Firing Problem

    DR (B)(6) REACHED OUT AGAIN REGARDING THE QUALITY OF BPU. HE EXPRESSED COMPLAINTS AGAIN REGARDING THE THROW LENGTH ADJUSTER MOVING FROM DESIRED LENGTH. HE DID NOT USE A CO-AXIAL. THE DEVICE WAS SET TO THE 23MM LENGTH AND FIRED AT THE 33MM LENGTH. THIS HAPPENED WITH ONE DEVICE WHICH WILL BE SENT BACK, THEY HAD AN ADDITIONAL 25 UNITS ON THE SHELF AND REQUESTED THAT I SEND THEM ALL BACK TO QUALITY.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16963987 ↗

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 · Terminated
    BioPince 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

Other Instrument, Biopsy devices

All Instrument, Biopsy devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page