BioPince™ Ultra Full Core Biopsy Instrument 370-1080-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00886333224067), received between Mar 31, 2022 and Apr 30, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024

  PATIENT WAS HERE FOR AN ULTRASOUND GUIDED RIGHT BREAST BIOPSY. A BIOPINCE DEVICE WAS OPENED AND TESTED PRIOR TO USE AND APPEARED TO FUNCTION PROPERLY. THREE PASSES WERE DONE IN THE BREAST AND SPECIMENS WERE NOT BEING CAPTURED. A SECOND BIOPINCE DEVICE WAS OPENED AND TESTED, AND THE BIOPSY WAS SUCCESSFULLY COMPLETED. DEFECTIVE DEVICE INFO: BIOPINCE 16 GAUGE X 10CM, LOT # 11501605, REF # 370-1080-02.

  Patient problems: Insufficient Information

  MAUDE report 19212341 ↗
• MalfunctionNov 22, 2023Failure to Obtain Sample; Failure to Obtain Sample

  2 SUBSEQUENT ULTRASOUND GUIDED LIVER BIOPSIES HAD BIOPSY SAMPLES TAKEN WITH NEEDLE APPROPRIATELY POSITIONED, NEEDLE GUN DEPLOYED, BUT NO BIOPSY SAMPLE OBTAINED. SAME TECHNIQUE AS HUNDREDS OF SUCCESSFUL PRIOR STANDARD LIVER BIOPSIES. THIS CREATES ADDITIONAL PATIENT RISK OF BLEEDING AS FURTHER BIOPSY SAMPLES ARE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194006 ↗
• MalfunctionNov 2, 2023

  PATIENT WAS HERE FOR A BREAST BIOPSY. THE RADIOLOGIST PLACED THE FIRST BIOPINCE DEVICE INTO THE PATIENT AND ATTEMPTED TO COLLECT TISSUE 3 SEPARATE TIMES, AND THE TISSUE SAMPLE WOULD NOT DISPENSE FROM THE BIOPINCE. THEREFORE, A SECOND BIOPINCE DEVICE WAS OPENED. THE SECOND DEVICE DEPLOYED AS EXPECTED, BUT WHEN THE RADIOLOGIST OPENED THE DEVICE TO COLLECT THE SAMPLE, THE HANDLE BROKE. THEREFORE, A THIRD DEVICE WAS OPENED TO COMPLETE THE BIOPSY SUCCESSFULLY. BOTH DEVICES HAVE THE REF#: 370-1080-02, LOT#: 11488229, EXP DATE: 2026-07-19.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18054720 ↗
• MalfunctionApr 13, 2023Firing Problem; Firing Problem

  WHEN FIRE BUTTON WAS PRESSED, IT DID NOT FIRE THE NEEDLE AND THE BUTTON STAYED DEPRESSED. WHEN RADIOLOGIST REMOVED THE NEEDLE FROM THE PATIENT, THE NEEDLE RANDOMLY FIRED ON IT¿S OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733416 ↗
• MalfunctionMar 1, 2023Firing Problem; Firing Problem

  PHYSICIAN REPORTS THAT DURING A PROCEDURE WITH 1 UNIT; THE DEVICE FEELS HARD AT THE TIME OF CHARGING. IN A FIRST PASS, THERE IS A DELAYED SHOT FROM THE MOMENT THE SHOT BUTTON IS PRESSED. IN THE SECOND PASS, THE DELAY IS MUCH LONGER, AND THE DOCTOR DECIDES TO EXTRACT THE GUN AND JUST AT THAT MOMENT THE NEEDLE CAME OUT AND FIRED ITSELF. THE CLIENT HAS DESCRIBED IT AS A VERY SERIOUS FAILURE THAT COULD HAVE TOUCHED A STRUCTURE WITH A RISK OF AFFECTING THE PATIENT'S HEALTH. USED UNIT IS SENT IN A DOUBLE BAG, FOR REVIEW AT ARGON. THEY NEED A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT.

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

  MAUDE report 16458239 ↗
• MalfunctionDec 6, 2022Break

  DEVICE BROKE THE SPRING MECHANISM BROKE AND ALMOST HIT THE NURSE IN THE EYE. 2ND DEEP ABDOMINAL BIOPSY, HIGH RISK.

  Patient problems: Insufficient Information

  MAUDE report 15926408 ↗
• MalfunctionOct 23, 2022Therapeutic or Diagnostic Output Failure; Activation Failure

  PHYSICIAN REPORTS THAT DURING PROCEDURE WITH SEVERAL UNITS OF THE SAME BIOPINCE: ADVANCE SELECTION FAILURE, SELECT AN ADVANCE BEFORE FIRING 23MM AND THE NEEDLE FIRES AT 33MM. THE ADVANCE IS CHANGED ONLY DURING THE SHOT. PHYSICIAN CONSIDER IT A SERIOUS INCIDENT, SINCE THEY CAN PERFORATE ANY STRUCTURE DUE TO THIS FAILURE, CREATING VERY SERIOUS INJURIES. ALSO FROM THE SAME BIOPINCE BOX, WHEN TRYING TO SHOOT THEM INSIDE THE PATIENT, THE SHOT CANNOT BE ACTIVATED. AND AFTER, THE FOURTH UNIT, ALSO FROM THE SAME BIOPINCE BOX, WAS ONLY CHARGED OUTSIDE WHEN SHOWING THE SOUND TO THE PATIENT. BUT ONCE LOADED IT WAS IMPOSSIBLE TO ACTIVATE THE SHOT. THAT LAST UNIT OF THE DEVICE WITHOUT CONTACT WITH PATIENT, HAS BEEN RECEIVED FROM THE HOSPITAL FOR STUDY BY ARGON CLEANED WITHIN A DOUBLE BAG. HOSPITAL HAS MORE UNITS OF THE MATERIAL BLOCKED FROM THIS LOT NUMBER. HOSPITAL NEEDS A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT AND WACREES NEEDS CREDIT NOTE PER 1 UNIT OF THE SAME REFERENCE.

  Patient problems: Insufficient Information

  MAUDE report 15656686 ↗
• MalfunctionApr 10, 2022Retraction Problem

  THE PINCHER IS FAILING TO RETRACT BACK INTO THE DEVICE ONCE THE BIOPSY HAS BEEN TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 14069279 ↗
• MalfunctionApr 10, 2022Retraction Problem

  THE PINCHER IS FAILING TO RETRACT BACK INTO THE DEVICE ONCE THE BIOPSY HAS BEEN TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 14069277 ↗
• MalfunctionApr 10, 2022Retraction Problem

  THE PINCHER IS FAILING TO RETRACT BACK INTO THE DEVICE ONCE THE BIOPSY HAS BEEN TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 14069274 ↗
• MalfunctionMar 31, 2022Difficult or Delayed Activation; Defective Device

  PHYSICIAN REPORTS THAT DURING THE USE OF THE DEVICE, A LOT OF EFFORT IS REQUIRED TO FIRE THE TWO TRIGGERS (FRONT AND REAR ONES), AND THE PATIENT IS IN DANGER OF AFFECTING SENSITIVE STRUCTURES NEAR THE BIOPSY SITE, WITH THE DANGER OF SIGNIFICANT BLEEDING. IN ADDITION, IN SOME CASES AFTER THE EFFORT OF THE SHOT, THE SAMPLES OBTAINED ARE BROKEN OR SCARCE. THE HOSPITAL HAS LOST CONFIDENCE IN THE PRODUCT AND RETURNS 5 UNUSED UNITS. FROM THE SAME BATCH. HOSPITAL NEEDS A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT AND WACREES NEEDS CREDIT NOTE PER 5 UNITS OF THE SAME REFERENCE.

  Patient problems: Insufficient Information

  MAUDE report 13969963 ↗
• MalfunctionMar 31, 2022Use of Device Problem

  PHYSICIAN REPORTS THAT THIS IS A PROBLEM THAT IS REPEATED IN DIFFERENT PROCEDURES. IN THIS CASE, DURING THE USE OF THE DEVICE, A LOT OF EFFORT IS REQUIRED TO FIRE THE TWO TRIGGERS, AND THE PATIENT IS IN DANGER OF AFFECTING SENSITIVE STRUCTURES NEAR THE BIOPSY SITE, WITH THE DANGER OF SIGNIFICANT BLEEDING. IN ADDITION, IN SOME CASES AFTER THE EFFORT OF THE SHOT, THE SAMPLES OBTAINED ARE BROKEN OR SCARCE. THE HOSPITAL HAS LOST CONFIDENCE IN THE PRODUCT AND RETURNS 38 UNUSED UNITS PLUS 2 DOUBLE-BAGGED USED UNITS (ONE STERILE UNIT); A TOTAL OF 40 SAMPLE UNITS FROM THE SAME BATCH. HOSPITAL NEEDS A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT AND WACREES NEEDS CREDIT NOTE PER 40 UNITS OF THE SAME REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13968796 ↗

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