BioPince™ Full Core Biopsy Instrument 370-1080-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333004386), received between Feb 3, 2021 and Jul 6, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (3 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.

• InjuryJul 6, 2024Failure to Obtain Sample; Failure to Obtain Sample

  DEVICE USED FOR A LUNG BIOPSY. DESPITE APPARENTLY NORMAL OPERATION, THAT IS TO SAY THAT THE DEVICE RETRACTED WHEN THE USER PRESSED THE ¿RETRACTION BUTTON¿ BUT NO TISSUE WAS TAKEN.AFTER FOUR UNSUCCESSFUL ATTEMPTS WITH THIS DEVICE, ANOTHER BIOTWEEZER FROM ANOTHER BATCH WAS USED WITHOUT ANY PROBLEMS. MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 19685845 ↗
• MalfunctionOct 16, 2023Failure to Obtain Sample; Material Twisted/Bent; Failure to Obtain Sample; Material Twisted/Bent

  THE SURGEON USED THE NEEDLE FOR THE FIRST CORE BIOPSY SPECIMEN. THE PATIENT EXPERIENCED A LOT OF PAIN AND DISCOMFORT. UPON OBTAINING THE FIRST SPECIMEN HE EXAMINED THE NEEDLE AND SAW IT WAS BENT. HE THEN CHANGED TO ANOTHER NEEDLE, THE SAME TYPE AND SIZE. TWO MORE SPECIMENS WERE OBTAINED. THE PATIENT DID NOT EXPERIENCED PAIN AND DISCOMFORT WITH THE 2ND NEEDLE.

  Patient problems: Discomfort; Pain

  MAUDE report 17941841 ↗
• MalfunctionAug 18, 2022Use of Device Problem; Mechanics Altered

  ON JULY 8, LYMPH NODE PUNCTURE, THE TISSUE COULD NOT BE REMOVED DURING THE OPERATION. AFTER TAKING OUT THE BIOPSY NEEDLE AND TRYING SEVERAL TIMES, IT WAS FOUND THAT THE SPRING FELL OFF. THE DIRECTOR SAID THAT IT HAD CAUSED PSYCHOLOGICAL AND PHYSICAL DAMAGE TO DOCTORS AND PATIENTS.; THIS EVENT WAS NOT USED WITH A COAXIAL GUIDE NEEDLE. THE GUN WAS NOT TESTED BEFORE USE. THE INSTRUMENT WAS NOT ROTATED 360 DEGREES WHEN IT WAS TAKEN OUT. THE RANGE OF USE WAS 23MM. THE EMPTY GUN OCCURRED AT THE FIRST NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 15248655 ↗
• InjuryMay 16, 2022Crack; Improper or Incorrect Procedure or Method

  THE NEEDLE WAS CRACKED AND SAMPLING WAS NOT POSSIBLE; THIS INCIDENT WAS NOT USED WITH A COAXIAL GUIDE NEEDLE, THE GUN WAS NOT TESTED BEFORE USE, THE INSTRUMENT WAS NOT ROTATED 360 DEGREES WHEN IT WAS TAKEN OUT, THE RANGE OF USE WAS 23MM, AND THE EMPTY GUN OCCURRED AT THE FIRST NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 14407569 ↗
• MalfunctionApr 21, 2022Therapeutic or Diagnostic Output Failure

  PHYSICIAN REPORTS THAT ONCE THE DEVICE IS USED, NO SAMPLE IS TAKEN. AND IN ONE OF THE THREE USED UNITS, THE DOCTOR SAW RECOIL OF THE TAP THAT HOLDS THE SAMPLE WITH THE DANGER OF TEARING FOR THE PATIENT. HOSPITAL NEEDS A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENTS AND WACREES NEEDS CREDIT NOTE PER 3 UNITS OF THE SAME REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165230 ↗
• MalfunctionFeb 3, 2021Failure to Obtain Sample

  PHYSICIAN REPORTS THAT DURING PROCEDURE 3 UNITS OF THE DEVICE, THEY DO NOT TAKE SPECIMEN AND IN ONE OF THE UNITS, THE RECEDING OF THE TAB THAT HOLDS THE SAMPLE IS OBSERVED, WHICH IS A RISK OF TEARING FOR THE PATIENT. IT WAS A FAILURE WHEN PATIENT WAS PUNCTURED WITH THE NEEDLE AND NO SAMPLE WAS CAPTURED. NO DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276604 ↗

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