BioPince™ Full Core Biopsy Instrument 360-2080-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333004348), received between Oct 22, 2021 and Jun 10, 2025 — classified as 1 injury, 5 malfunctions.

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

• InjuryJun 10, 2025Failure to Obtain Sample; Failure to Obtain Sample

  REPORTER STATED "DURING A LIVER BIOPSY, NO TISSUE CAN BE OBTAINED DESPITE THE REGULAR PROCEDURE (2 X PUNCTIO SICCA WITH THE SAME BIOPINCE). CHANGE OF BIOPINCE, RENEWED PUNCTIO SICCA. WITH THE SAME ERROR. LOT AND REF NUMBER CHECKED, IT WAS THE SAME BATCH. THEN CHANGED TO ANOTHER BATCH AND IT WORKED WITHOUT ANY PROBLEMS. THE PATIENT HAD TO BE PRICKED 4 TIMES, WHICH MEANS AN UNNECESSARY AND INCREASED RISK OF BLEEDING."

  Patient problems: Insufficient Information

  MAUDE report 22180044 ↗
• MalfunctionDec 2, 2024Failure to Obtain Sample; Failure to Obtain Sample

  TWO DRY PUNCTURES DESPITE CORRECT HANDLING. THEN CHANGE TO ANOTHER NEEDLE AND REMOVE A BIOPSY CYLINDER WITHOUT COMPLICATIONS. THIS HAS HAPPENED SEVERAL TIMES NOW. A SECOND OR THIRD PUNCTURE CAN LEAD TO BLEEDING, PAIN OR EVEN A PNEUMOTHORAX. THIS IS BECAUSE PARENCHYMAL BIOPSY IS PERFORMED WITHOUT A NEEDLE. IN THE WORST CASE, A SECOND BIOPSY MAY BE NECESSARY IF NOT ENOUGH MATERIAL IS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821099 ↗
• MalfunctionJun 27, 2023Firing Problem; Firing Problem

  ¿BIOPINCE LOADED NORMALLY AND TRIGGERED AS A TEST DURING THE "SHOT" TEST. NOTHING NOTICEABLE. THEN DURING THE LIVER BIOPSY (NEEDLE IN THE PATIENT), THE "SHOT" CANNOT BE FIRED. WITHDRAWAL AND NEW BIOPINCE WITH PROBLEM-FREE BIOPSY. WHEN YOU THEN TRY AGAIN TO FIRE THE SHOT (NOT ON THE PATIENT), THIS SUCCEEDS WITHOUT ANY PROBLEMS. THEN YOU NOTICE THAT THE TIP IS NOT POINTED BUT JAGGED LIKE A CROWN. WASN'T THE CASE WITH THE FIRST TEST ATTEMPT OUTSIDE OF THE PATIENT. IN THIS CASE IT WAS PERFECT THAT THE SHOT COULD NOT BE FIRED WHEN THE NEEDLE WAS IN THE PATIENT. OUTSIDE THE PATIENT, HOWEVER, THE SHOT COULD BE FIRED WITHOUT ANY PROBLEMS, DESPITE THIS DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209399 ↗
• MalfunctionMar 28, 2023Break; Break

  I HAVE RECEIVED AN EMAIL FROM VIGILANCE DEPARTMENT OF INSELSPITAL BERN THAT A BIOPINCE WAS FULLY BREAKING IN PIECES WHEN THEY RELOADED THE SYSTEM. EVENT IS REPORTED TO SWISS MEDIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629796 ↗
• MalfunctionFeb 7, 2022Dull, Blunt

  THE PATIENT WAS PUNCTURED WITH THE NEEDLE, AND ALTHOUGH EVERYTHING WORKED, THERE WAS NO MATERIAL PUNCH TO BE GAINED. FROM THE PUNCTURE, ONE HAD THE FEELING THAT THE NEEDLE WAS STUMP. BECAUSE OF THIS, THREE NEEDLES (ALL WITH THE SAME LOT NUMBER) WERE USED. ON THE THIRD ATTEMPT, IT WORKED. THE PATIENT HAD TO BE PUNCTURED THREE TIMES AND THE RISK OF INFECTION INCREASES WITH EACH PUNCTURE. THIS CASE WAS REPORTED TO (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 13471307 ↗
• MalfunctionOct 22, 2021Break; Entrapment of Device

  SCHEDULED CT GUIDED BONE MARROW ASPIRATE AND CORE UNDER MONITORED ANESTHESIA CARE WAS IN PROGRESS. THE RIGHT ILIAC BONE WAS ACCESSED WITH AN INTRODUCER NEEDLE AND A 1 CM DISTAL TIP OF THE OUTER CANNULA OF THE CO-AXIAL INTRODUCER NEEDLE BROKE OFF AND WAS LEFT RETAINED DEEP WITHIN THE RIGHT ILIAC BONE. THE RISKS OF REMOVING THE FOREIGN BODY OUTWEIGHED THE BENEFIT OF LEAVING IT IN AND DECISION WAS MADE TO LEAVE THE FOREIGN BODY IN PLACE. CASE PROCEEDED TO CONCLUSION WITH NO ADDITIONAL PATIENT HARM OR EVENT. DEVICE WAS NOT SAVED FOR EVALUATION BY BIOMEDICAL BUT PACKAGING INFORMATION RETAINED. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12684127 ↗

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