BioPince Ultra Full Core Biopsy Instrument 360-1580-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333224029), received between Jun 28, 2022 and Apr 1, 2025 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Misfire; Misfire

  A LEAD CT TECH REPORTED THE DEVICE DISCHARGED WITHOUT BEING FIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741246 ↗
• MalfunctionOct 17, 2023Failure to Obtain Sample; Failure to Obtain Sample

  ATTEMPT AT INTRAHEPATIC BIOPSY WHICH WAS A FAILURE, BECAUSE BIOPINCE DID NOT RECOVER LIVER MATERIAL.

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

  MAUDE report 17951488 ↗
• InjuryOct 2, 2023Break; Break

  PATIENT UNDERGOING OUTPATIENT LUNG BIOPSY. DURING THE SECOND BIOPSY, THE DEVICE MADE A STRANGE SOUND. DEVICE WAS REMOVED AND FOUND TO BE BROKEN. THE LOCKING MECHANISM WOULD NOT FUNCTION AND WAS BROKE AWAY FROM IT'S USUAL LOCATION PER OPERATING MD. POST PROCEDURE CT SCAN SHOWED A PERICARDIAL EFFUSION REQUIRING PLACEMENT OF A PERICARDIAL DRAIN. PT WAS STABILIZED AND ADMITTED FOR MONITORING.

  Patient problems: Pericardial Effusion

  MAUDE report 17858307 ↗
• MalfunctionFeb 1, 2023Failure to Obtain Sample; Failure to Obtain Sample

  WE HAD TWO BIOPINCE DEVICES FAIL TO OBTAIN SAMPLES DURING A KIDNEY BIOPSY TODAY DESPITE A GOOD SAMPLING PATH SHOWN WITH ULTRASOUND GUIDANCE. EACH SAMPLE WAS ¿EMPTY¿ WHEN TRYING TO EXPEL THE CORE. INTERESTINGLY, THERE WAS A CORE FOUND LYING ON THE PATIENT AT ONE POINT AS IF IT HAD FALLEN FROM THE BIOPINCE AFTER OBTAINING A SAMPLE. AT LEAST 4 PASSES WERE MADE WITH EACH DEVICE BEFORE FINALLY USING A SIDE-CUT NEEDLE. I BELIEVE THE DEVICES MALFUNCTIONED PLACING THE PATIENT AT RISK OF INCREASED BLEEDING. ATTACHING THE PRODUCT PACKAGING LABELS FOR REFERENCE. PLEASE LET ME KNOW IF ANY OTHER INFORMATION IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278079 ↗
• MalfunctionOct 24, 2022Output Problem

  THE CUSTOMER HAVE HAD A NUMBER OF CASES WHERE THEY USED BIOPINCE 370-1580-02 AND 360-1580-02 AND THEY DIDN`T GET ANY TISSUE MATERIAL WITH THE FIRST DEVICE, IN SECOND TRY WITH A NEW DEVICE THEY SUCCEEDED. THEY HAVEN`T STORED ANY OF THE INVOLVED DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 15664402 ↗
• MalfunctionJun 28, 2022Output Problem; Positioning Problem

  THE THROW ADJUSTER IS VERY HEAVY TO MOVE, AND IT IS DIFFICULT TO HIT THE EXACT POINT WHERE IT SHOULD STOP. MOVING THE SELECTOR IS NOT SMOOTH, BUT CHOPPY THE DOCTOR THINKS IT IS IN PLACE, BUT IF IT IS SLIGHTLY IN FRONT, IT SHOOTS 33 MM, EVEN THOUGH THE CHOICE WAS MEANT TO BE 23 MM. EXPERIENCED VERY DANGEROUS, AND THEREFORE THE PBUS THAT HAVE A HEAVY BUTTON ARE DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 14841266 ↗

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