BioPince Ultra Full Core Biopsy Instrument 360-1080-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886333224005), received between Jul 21, 2020 and Feb 18, 2025 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Material Fragmentation; Material Fragmentation

  BIOPSY WAS PERFORMED ON PATIENT. AS SAMPLE WAS REMOVED, THE METAL OUTER CANNULA TIP OF THE DEVICE WAS EMBEDDED IN THE SAMPLE, THE NEEDLE PINCER WAS FULLY EXPOSED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392416 ↗
• MalfunctionJan 2, 2025Break; Break

  WHILE DOING A RENAL BIOPSY WITH DR INJECTED A NEEDLE TO GET A BIOPSY IN THE KIDNEY AND WHEN SHE PULLED OUT THE NEEDLE, WE NOTICED THAT IT WAS BROKEN. WHEN THEY SAW THE NEEDLE TIP WAS DAMAGED FROM THE SHEATH, THE GRASPING PORTION OF THE BIOPSY NEEDLE WAS NOT DEPLOYED. THEY OPENED A NEW BIOPSY NEEDLE AND USED THAT TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 21057883 ↗
• InjuryNov 21, 2024Failure to Obtain Sample; Failure to Obtain Sample

  WHEN THE SHOT IS FIRED INSIDE THE PATIENT TO OBTAIN THE SAMPLE, THE BIOPINCE IS OPENED. NEED FOR MEDICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY.

  Patient problems: Insufficient Information

  MAUDE report 20753991 ↗
• MalfunctionSep 10, 2024Firing Problem; Firing Problem

  REPORTER INDICATED "THE DEVICE WAS SET TO 1.3CM THROW AND FIRED CLOSER TO 2CM (SEE PASS 2 BELOW). PASSES 1 & 3 WERE FINE. BETWEEN PASS 2 AND 3 THE RESIDENT AND STAFF VERIFIED THE LENGTH, DID NOT CHANGE ANYTHING WITH THE DEVICE AND USED IT AGAIN FOR PASS 3 WHERE IT FIRED CORRECTLY AT 1.3CM. THIS IS A DIFFERENT STAFF AND RESIDENT THAN THE LAST MISFIRE AND NOW HAPPENED WITH AN 18GX10CM. IMAGES BELOW (PASS 2: FIRED TOO LONG; PASS 3: FIRED CORRECT LENGTH) HAPPY TO SEND UNMARKED IMAGES AS WELL GREEN ARROW IS THE WHERE THE TROUGH COMES OUT WHITE LINE IS THE LENGTH OF FIRE PINK ARROWS MARK THE PROXIMAL AND DISTAL ENDS OF THE TARGET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183517 ↗
• MalfunctionAug 28, 2024Break; Material Fragmentation; Break; Material Fragmentation

  REPORTER INDICATED "FRAGMENT BROKE OFF INTO SPECIMEN POT WHEN INSERTING FOLLOWING SAMPLE INSERTION INTO SPECIMEN POT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085439 ↗
• MalfunctionJul 5, 2024Break; Break

  DR (B)(6) PERFORMING A LIVER BIOPSY NOTICED THE BIOPINCE ULTRA NEEDLE FELT PECULIAR AND FIRING. HE REMOVED THE BIOPINCE ULTRA FROM THE BP COAXIAL. WHEN PLACING THE BIOPINCE OVER THE SAMPLE TABLE HE NOTICED A SMALL PIECE OF METAL DROP ONTO THE TABLE. ON CLOSER INSPECTION THIS WAS THE TIP OF THE BIOPINCE ULTRA AND THE CANNULA APPEARS TORN. BIOPINCE COAXIAL MCXS1810BP (NO LOT NUMBER RECORDED. NOT AVAILABLE FOR RETURN)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680662 ↗
• MalfunctionJul 2, 2024Firing Problem; Firing Problem

  THE REPORTER STATED FROM THE LEAD TECH AND PHYSICIAN'S PERSPECTIVE: "DR. (B)(6) WAS THE ATTENDING ON THE CASE FOR THE RENAL BX. ON THE FIRST PASS, THE DEVICE FIRED AND COLLECTED A SAMPLE, BUT IT WAS BELIEVED THE DEVICE FIRED AT 33MM INSTEAD OF THE SELECTED 23MM THROW LENGTH. THE DEVICE WAS OBSERVED AND THE THROW LENGTH ADJUSTER WAS STILL ON THE 23 MM THROW LENGTH. A SECOND PASS WAS DONE AND MEASUREMENT ON THE US MACHINE SHOWED THE DEVICE DID FIRE AT 33 MM INSTEAD OF THE SELECTED 23, AND THE THROW LENGTH ADJUSTER WAS STILL AT THE SELECTED 23 MM. A NEW DEVICE WAS OPENED, TESTED, AND USED FOR THE REMAINED OF THE BX. THAT DEVICE WAS INSPECTED BY DR. (B)(6) AND DR. (B)(6) AS WELL, AND THEY ALL AGREED THE DEVICE WAS FIRING ON THE 33MM LENGTH EVEN THOUGH THE THROW LENGTH ADJUSTER WAS ON THE 23 MM THROW. WHEN LOOKING BACK AT THE US IMAGES, IT LOOKS LIKE THE DEVICE JUMPS BACK AND THEN FORWARD WHEN FIRED. TWO OTHER DEVICES OF THAT LOT WE OPENED AND TESTED AND APPEARED TO BE FINE AND FIRING CORRECTLY AT THE 23 MM THROW." THE CUSTOMER DOES NOT HAVE THE NEEDLE USED FOR THE CASE WITH THE INITIAL ISSUE, THE RESIDENT DISCARDED IT. THEY HAVE THE LABEL FROM THE PACKAGING. THERE IS A VIDEO OF THE SEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662831 ↗
• InjuryJul 2, 2024Defective Device; Defective Device

  REPORTER INDICATED "HIGH NUMBER OF REVISIONS FOR RECTAL BLEEDING FOLLOWING THE USE OF THESE BIOPSY NEEDLES PROSTATE (5 IN 1 MONTH, 3 DIFFERENT OPERATORS).FOR THE UROLOGY TEAM, THE BEVEL IS REVERSED ON THESE NEEDLES. THIS CAN CAUSE INJURY AND BLEEDING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19662766 ↗
• MalfunctionJun 28, 2024Failure to Obtain Sample; Failure to Obtain Sample

  REPORTER INDICATED "BEDSIDE PORTABLE FOR LIVER BIOPSY ON (B)(6) 2024 WITH DR. (B)(6). 2 PASSES WERE TAKEN WITH BIOPINCE BIOPSY 16GA X 10CM NEEDLE: THE PASSES FAILED AT 0921 & 0922. UNFORTUNATELY, THE DOCTOR HAD TO USE ANOTHER BIOPSY DEVICE TO COMPLETE THE PROCEDURE, WHICH ENTAILED 2 MORE PASSES. THE PATIENT WAS IN EXTREME PAIN POST PROCEDURE." IMMEDIATE ACTIONS TAKEN: THE DOCTOR REPLACED THE FAILING WITH A DEVICE WITH ANOTHER DEVICE. INFORMED SUPERVISOR OF THE DEPARTMENT OF WHAT TRANSPIRED. ADDITIONALLY, THE PATIENT WAS HYPOTENSIVE, PATIENT HAD AN ANGIO/CTA PERFORMED BY THE ON CALL TEAM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19635868 ↗
• MalfunctionJun 19, 2024Break; Break

  ARGON BIOPINCE BIOPSY INSTRUMENT 18GA X 10CM GOT STUCK IN THE INTRODUCER NEEDLE WHICH WAS IN A PATIENT DURING BIOPSY PROCEDURE. THE CIR REMOVED IT FROM THE PATIENT TO CHECK THE EQUIPMENT, ON EXAMINATION OF BOTH NEEDLES THE BIOPSY INSTRUMENTS NEEDLE WAS FOUND TO HAVE A KINK/SPLIT IN IT AND THEN THE TIP SNAPPED OFF ON EXAMINATION.

  Patient problems: Insufficient Information

  MAUDE report 19568121 ↗
• MalfunctionApr 1, 2024Failure to Obtain Sample; Failure to Obtain Sample

  AN ULTRASOUND MANAGER REPORTED THAT DURING A KIDNEY BIOPSY, 4 PASSES WERE PERFORMED WITH NO SPECIMEN RECEIVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015333 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  WOULD NOT TAKE SAMPLE ON FIRST TRY. DREW BLANK. DR STATED ¿THEY FIRE AND YOU GET BLANKS. HAPPENED MULTIPLE TIMES WITH MULTIPLE PATIENTS. THESE HAVE OCCURRED ON HIGH RISK PATIENTS WHO HAVE LOW PLATELETS/LUPUS AND HIGH RISK FOR BLEEDS AND REQUIRING MULTIPLE BIOPSIES." THERE HAVE BEEN NO REQUIRED MEDICAL INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691517 ↗
• MalfunctionDec 18, 2023Firing Problem; Firing Problem

  WE HAVE HAD SOME MISS FIRES. THE SHORT BIOPINCE WAS SET AT 2.3 CM, BUT ACQUIRED 3.3CM SAMPLES (TWO TIMES). IT FIRED NORMALLY ONCE. THIS HAS HAPPENED IN THE PAST, BUT I WAS NOT 100% CONVINCED THAT IT WAS NOT MY IMAGINATION. SO, I RECOMMEND HAVING AT LEAST A 3.4CM DISTAL SAFETY ZONE WHEN FIRING THE GUN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352597 ↗
• MalfunctionDec 18, 2023Firing Problem; Firing Problem

  WE HAVE HAD SOME MISS FIRES. THE SHORT BIOPINCE WAS SET AT 2.3 CM, BUT ACQUIRED 3.3CM SAMPLES (TWO TIMES). IT FIRED NORMALLY ONCE. THIS HAS HAPPENED IN THE PAST, BUT I WAS NOT 100% CONVINCED THAT IT WAS NOT MY IMAGINATION. SO, I RECOMMEND HAVING AT LEAST A 3.4CM DISTAL SAFETY ZONE WHEN FIRING THE GUN¿.¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352589 ↗
• MalfunctionOct 17, 2023Failure to Obtain Sample; Failure to Obtain Sample

  I SPOKE TO THE SENIOR CHARGE NURSE IN RADIOLOGY, (B)(6) WHO ADVISED ME THAT DR. (B)(6) WHO IS A VERY EXPERIENCED CONSULTANT, HAS HAD TWO ISSUES RECENTLY WHEN TRYING TO USE BIOPINCE. THE BIOPINCE THAT IS BEING RETURNED ALONGSIDE THIS REPORT, IS RELATED TO THE INCIDENT THAT OCCURRED ON THE (B)(6) 2023. DR. (B)(6) WAS TRYING TO TAKE A BIOPSY FROM A LUNG, USING C.T SO IS VERY CONFIDENT HE WAS WHERE HE NEEDED TO BE BUT HE HAS ADVISED THE BIOPINCE FAILED TO RETRIEVE A SAMPLE. AS A SIMILAR THING HAPPENED JUST A FEW WEEKS BEFORE, HE BELIEVES IT IS A FAULT WITH THE BIOPINCE. DR. (B)(6) HAS BEEN USING BIOPINCE FOR YEARS AND SO HAS A LOT OF EXPERIENCE. HE SENT THE EMAIL BELOW WITH THE EXTRA DETAIL TO SISTER (B)(6). FROM: (B)(6) SENT: 19 SEPTEMBER 2023 15:07 TO: (B)(6) SUBJECT: RE: BIOPINCE HI (B)(6), I WAS THE OPERATOR. DATE OF THE MORE RECENT INCIDENT WAS (B)(6) 2023 PROCEDURE WAS A LUNG BIOPSY PATIENT INJURY: THE PROCEDURE WAS PROLONGED WITH INCREASED DISCOMFORT TO PATIENT AND RISK OF PNEUMOTHORAX. IF I HAD NOT SUCCESSFULLY USED A SECOND GUN AND THE PATIENT HAD AN INADEQUATE BIOPSY THEY WOULD HAVE HAD A DELAY TO POTENTIALLY LIFE SAVING TREATMENT AND WITHOUT THE BIOPSY A RISK OF NOT GETTING

  Patient problems: Discomfort

  MAUDE report 17950104 ↗
• MalfunctionAug 29, 2023Failure to Obtain Sample; Failure to Obtain Sample

  KIDNEY BIOPSY WITH COAX. MADE 8 PASSES WITH TWO GUNS AND ONLY GOT 2 GOOD SAMPLES. THE REST WERE ALL FRAGMENTED AND UNUSABLE. DR. (B)(6) IS CONCERNED WITH BLEEDING RISK WHEN MULTIPLE PASSES ARE NOT COLLECTING A SAMPLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643889 ↗
• MalfunctionMar 1, 2023Firing Problem; Firing Problem

  PHYSICIAN REPORTS THAT DURING A PROCEDURE WITH 1 UNIT; AFTER ENSURING THE PLACEMENT OF THE LEAD IN THE INTERMEDIATE POSITION (2.4 CM), WHEN FIRING IT IS SEEN THAT THE ACTUAL LEAD INSIDE THE PATIENT HAS TURNED OUT TO BE 3.4 CM. WHEN THE POSITION IS CHECKED, IT IS SEEN THAT IT HAS CHANGED ITSELF TO THE POSITION OF MAXIMUM LENGTH. THE HOSPITAL SAYS THAT IT IS A SERIOUS INCIDENT THAT COULD HAVE CAUSED SERIOUS DAMAGE TO THE INTEGRITY OF THE PATIENT. USED UNIT IS SENT IN A DOUBLE BAG, FOR REVIEW AT ARGON. THEY NEED A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENTS.

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

  MAUDE report 16458369 ↗
• MalfunctionMar 1, 2023Firing Problem; Firing Problem

  PHYSICIAN REPORTS THAT DURING A PROCEDURE WITH 1 UNIT; IN A FIRST ATTEMPT TO SHOOT, THIS DOES NOT OCCUR. HOWEVER, A FEW SECONDS LATER, HE SHOOTS HIMSELF WITHOUT ANY MEDICAL SUPERVISION. THE DOCTORS CLASSIFIED WHAT HAPPENED AS SERIOUS, SINCE IT PUTS THE INTEGRITY OF THE PATIENT AT RISK.. THE HOSPITAL RETURNS THE USED UNIT 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 16458290 ↗
• InjuryJan 3, 2023Firing Problem; Mechanics Altered; Firing Problem; Activation Problem

  PHYSICIAN REPORTED "DURING A THYROID BIOPSY, THE DOCTOR HAD SELECTED A NEEDLE ADVANCE OF 1.3 CM. WHEN SHOOTING, THE NEEDLE HAS ADVANCED 3.3 CM, SO IT HAS CROSSED THE VERTEBRAL ARTERY, CAUSING HEMORRHAGE IN THE PATIENT VERY DIFFICULT TO CONTROL. THE EVENT HAS BEEN SERIOUS AND THERE IS TALK OF THE POSSIBILITY OF CREATING A HEALTH ALERT".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16088972 ↗
• MalfunctionSep 13, 2022Mechanics Altered

  2 DEVICES IN THE SAME LOT COLLECTED LONGER SAMPLE THAN THE SET THROW LENGTH. MOST RECENT OCCURRENCE WAS SET TO 2.3CM AND COLLECTED 4CM SAMPLES. DOCTOR SET THE LENGTH ON THE EXACT NOTCH AND NOT IN BETWEEN.

  Patient problems: Laceration(s)

  MAUDE report 15410910 ↗
• MalfunctionAug 24, 2022Firing Problem; Difficult to Remove; Mechanics Altered; Firing Problem

  PHYSICIAN REPORTS THAT DURING PROCEDURE 1 UNIT OF THE DEVICE, IN A FIRST SHOT THE NEEDLE ADVANCES MORE THAN PREVIOUSLY SELECTED. WHICH COULD HAVE CAUSED INJURY TO THE ORGAN IN QUESTION. WHEN REMOVING THE DEVICE FROM THE PATIENT'S BODY AND TRYING TO OBTAIN THE SPECIMEN, THE TIP DOES NOT COME OUT (POSSIBLY IT WOULD BE BLOCKED INSIDE THE CANNULA) AND THE LOADING BUTTON IS BLOCKED. WE HAVE RECEIVED 1 WASHED USED UNIT INSIDE A DOUBLE BAG FROM THE HOSPITAL FOR STUDY BY ARGON. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283462 ↗
• MalfunctionJul 14, 2022Material Too Rigid or Stiff; Unintended Movement

  THE FIRST NEEDLE WE OPENED AND WANTED TO USE WAS FAULTY, STIFF AND JUMPS THE SET CM WHICH WAS PRE-SET. WE WERE VERY CONCERNED AS THIS IS VERY RISKY TO OUR PATIENTS IF THIS HAD OCCURRED DURING PROCEDURE, IT COULD HAVE DAMAGED OTHER SURROUNDING ORGANS. I HAVE KEPT THE FAULT NEEDLE JUST IN CASE WE MIGHT HAVE A REP AT SITE OR DISCUSS THIS WITH ANY OF YOUR EQUIPMENT REPS. IS THERE ANYONE I CAN SPEAK TO OR DISCUSS THIS ISSUE WITH?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014903 ↗
• MalfunctionJun 9, 2022Material Twisted/Bent; Therapeutic or Diagnostic Output Failure

  PHYSICIAN REPORTS THAT DURING USE OF THE TWO DEVICES IT IS OBSERVED THAT THEY DO NOT TAKE A SAMPLE AND THE GRIP TAB APPEARS TWISTED. THE PATIENT FELT A LOT OF PAIN WHEN THE GUN WAS REMOVED THE HOSPITAL DIDN¿T SEND SAMPLES, BUT SEND SEVERAL IMAGENS. THEY NEED A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT AND WACREES NEEDS CREDIT NOTE PER 2 UNITS OF THE SAME REFERENCE.

  Patient problems: Pain

  MAUDE report 14644243 ↗
• MalfunctionMay 6, 2022Product Quality Problem; Therapeutic or Diagnostic Output Failure

  WE'VE HAD TWO THAT DID NOT PRODUCE A "SAMPLE". ONE WAS ABOUT A MONTH AGO ON A KIDNEY BIOPSY (WITH DR. H), THE OTHER WAS YESTERDAY ON A BREAST BIOPSY (WITH DR. S). I WOULD ASSUME THEY CAME FROM DIFFERENT LOTS (WE GO THROUGH AT LEAST 5 TIMES THE NEEDLES AT (B)(6)). DR. H TRIED 2 BIOPSIES WITH THE NEEDLE BEFORE SWITCHING TO ANOTHER, AS DID DR. S. THERE WAS ABSOLUTELY NO TISSUE SAMPLE IN THE CHAMBER. KIDNEYS ARE VERY VASCULAR (BLEED EASLIY). SO WE TYPICALLY TAKE ONLY 2-3 BIOPSIES. THIS PATIENT HAD TO HAVE A TOTAL OF 5 WHICH IS UNACCEPTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305080 ↗
• MalfunctionJan 17, 2022Detachment of Device or Device Component

  METAL PIECE FROM NEEDLE DETACHED, DURING BIOPSY, ULTRASOUND DEPARTMENT.

  Patient problems: Insufficient Information

  MAUDE report 13266048 ↗

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