BioPince Ultra Full Core Biopsy Instrument 360-1580-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886333224036), received between Nov 2, 2021 and Jan 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (2 reports).

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Failure to Obtain Sample

  A CUSTOMER REPORTED A PHYSICIAN WAS PERFORMING RENAL BIOPSY AND THE DEVICE WAS FIRING BUT NOT COLLECTING SAMPLES AFTER THE FIRST PASS. 1 OF THE 10 PASSES ATTEMPTED ONLY COLLECTED A SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218109 ↗
• MalfunctionMay 19, 2025Misfire; Misfire

  A RADIOLOGIST ATTEMPTED TO USE THE SIDE BUTTON TO FIRE THE DEVICE DURING A RENAL BIOPSY. THE SIDE BUTTON FAILED; THE PHYSICIAN THEN ADJUSTED HIS HAND TO USE THE TRIGGER AT THE BACK OF THE NEEDLE AND THE DEVICE DEPLOYED WITHOUT ANY BUTTONS BEING PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047245 ↗
• MalfunctionNov 20, 2023

  WHILE PROVIDER WAS PERFORMING BIOPSY, HE NOTICED THE NEEDLE HAD SOME RESISTANCE. HE REMOVED THE NEEDLE WITH THE SAMPLE AND INSPECTED THE NEEDLE, AND NOTICED SOME BARBS ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169134 ↗
• MalfunctionMar 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  (B)(6) PERFORMED 4 PASSES WITH THE BIOPINCE ULTRA. AFTER 4 ATTEMPTS THERE WAS NO SAMPLE TISSUE PRESENT. DOCTOR TRIED THE DEVICE ON A GEL AND THERE WAS NO CORE CAPTURED EITHER. PATIENT EXPERIENCED SOME BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16529930 ↗
• MalfunctionJan 24, 2023Material Too Rigid or Stiff; Material Twisted/Bent; Sharp Edges; Material Twisted/Bent

  THE SHANK OF THE NEEDLE IS VERY STIFF. AND WHEN TAKING THE SAMPLE THE NEEDLE CAME OUT LIKE A CARVING KNIFE, WHICH CAUSED MORE THAN NORMAL BLEEDING IN THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16233394 ↗
• MalfunctionAug 29, 2022Misfire

  BPU ¿MISFIRED WHILE IN PATIENTS BODY."

  Patient problems: Insufficient Information

  MAUDE report 15313094 ↗
• MalfunctionNov 2, 2021Failure to Fire

  DURING BIOPSY, TRIED TO SAMPLE BIOPSY WITH BIOPINCE GUN. IT WOULD NOT FIRE PER MD. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12745280 ↗

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