BioPince Ultra Full Core Biopsy Instrument 360-1080-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00886333224012), received between Jun 16, 2021 and Mar 5, 2025 — classified as 2 deaths, 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Wrong Label; Wrong Label

  BIOPINCE WITH 15 CM LENGTH WAS PACKED IN PACKAGING MARKED 10 CM LENGTH. DEVICE WAS USED ON PATIENT WITH CO-AXIAL NEEDLE CT GUIDED. UPON USE THE BIOPINCE PENETRATED 5 CM LONGER THAN ANTICIPATED AND PLANNED RESULTING IN BLEEDING AND TISSUE DAMAGE. CUSTOMER HAS SO FAR NOT SHARED THE EXTENT OF PATIENT IMPACT. CUSTOMER IDENTIFIED THREE MORE BIOPINCE WHERE LENGTH OF DEVICE DID NOT MATCH WHAT WAS MARKED ON THE PACKAGING. THESE WERE NOT USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21531818 ↗
• MalfunctionDec 4, 2024Firing Problem; Firing Problem

  OPERATOR SAYS SYSTEM WAS TAKING 33CM THROW WHEN SET TO 23CM

  Patient problems: Insufficient Information

  MAUDE report 20850085 ↗
• MalfunctionSep 23, 2024Failure to Fire; Failure to Fire

  REPORTER INDICATED ¿I COULDN¿T GET THE SIDE BUTTON TO FIRE, KEPT PRESSING, NO RESULT. AS SOON AS I LET GO TO REMOVE THE DEVICE AND GET A NEW ONE, IT FIRED AND CAUSED THE PATIENT A TON OF PAIN."

  Patient problems: Pain

  MAUDE report 20287771 ↗
• MalfunctionMay 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT DURING A BIOPSY SAMPLE THE BLUE LID OF THE DEVICE SNAPPED OFF WHEN BEING PRIMED ON ONE OCCASION. THE DEVICE HAD ALREADY BEEN USED FOR ONE BIOPSY, SO THE CUSTOMER DISPOSED OF IT AND IT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245746 ↗
• DeathOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) WENT TO BIOPSY A LYMPHNODE IN THE RIGHT SIDE OF A PATIENT GROIN. BACKGROUND ON PATIENT: HAD SMALL PE,DIFFUSED LYMPHOMA, AND ON LOVENOX AFTER BIOPSY, DR. (B)(6) NOTICE HE HIT A SMALL ACCESSORY ARTERY ABOUT 1MM WIDE. THE PATIENT STARTED TO BLEED. THEY HAD TO EMBOLIZE THE PATIENT TO STOP THE BLEEDING. SHORTLY AFTER THE EMBOLIZATION THE PATIENT PASSED AWAY. HE CLAIMS A 18G BPU WAS USED BUT DOESN'T REMEMBER THE LENGTH. SIDE NOTE: THE DOCTOR DOES NOT BLAME THE DEVICE, BUT ATTRIBUTES THE CAUSE AS "BAD LUCK".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17941391 ↗
• MalfunctionAug 29, 2023Firing Problem; Activation Problem; Firing Problem; Activation Problem

  DR (B)(6) MADE THE FIRST PASS AND RETRIEVED A SAMPLE. WHEN HE RE-CHARGED THE BIOPINCE, IT SEEMED TO BREAK AT THE HANDLE, BUT APPEARED TO RECHARGED THE DEVICE. HE MADE ANOTHER PASS WITH THE DEPTH SELECTOR SWITCH SET TO 23MM THROW, AND THE DEVICE WENT BEYOND THE 23MM DEPTH AND PIERCED THE LUNCH. THE PATIENT CRASHED AND HAD A NEUMO THORAX DEVELOP. THE PATIENT WAS TRANSFERRED TO SMH MAIN AND IS DOING WELL

  Patient problems: Pneumothorax

  MAUDE report 17644044 ↗
• MalfunctionJun 27, 2023Firing Problem; Firing Problem

  PHYSICIAN SET THROW LENGTH, FIRED BPU DEVICE AND THE THROW LENGTH BUTTON MOVED FORWARD AND THE DEVICE THREW FURTHER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208873 ↗
• MalfunctionJun 15, 2023Failure to Obtain Sample; Failure to Obtain Sample

  RENAL BIOPSY PERFORMED OF LEFT KIDNEY. BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT, WHEN DEPLOYED, WOULD NOT SMOOTHLY ACCESS CORE BIOPSY SAMPLE. MULTIPLE ATTEMPTS WERE MADE AND A NEW BIOPINCE ULTRA WAS OPENED. THE SAME DIFFICULTY WAS EXPERIENCED WITH THE SECOND DEVICE RESULTING IN BLEEDING AND HEMATOMA FORMATION THAT REQUIRED AN INTERVENTION. NO BLOOD TRANSFUSION REQUIRED. REFERENCE REPORT: MW5118111.

  Patient problems: Hematoma

  MAUDE report 17139146 ↗
• MalfunctionJun 15, 2023Failure to Obtain Sample; Failure to Obtain Sample

  RENAL BIOPSY PERFORMED OF LEFT KIDNEY. BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT, WHEN DEPLOYED, WOULD NOT SMOOTHLY ACCESS CORE BIOPSY SAMPLE. MULTIPLE ATTEMPTS WERE MADE AND A NEW BIOPINCE ULTRA WAS OPENED. THE SAME DIFFICULTY WAS EXPERIENCED WITH THE SECOND DEVICE RESULTING IN BLEEDING AND HEMATOMA FORMATION THAT REQUIRED AN INTERVENTION. NO BLOOD TRANSFUSION REQUIRED. REFERENCE REPORT: MW5118112.

  Patient problems: Hematoma

  MAUDE report 17138012 ↗
• MalfunctionApr 18, 2023Failure to Obtain Sample; Failure to Obtain Sample

  (B)(6) STATED THE DEVICE DID NOT COLLECT ADEQUATE SAMPLES AND CAUSED TEMPORARY PATIENT BLEED THAT WAS RESOLVED. A CO-AX WAS USED IN THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16761490 ↗
• MalfunctionApr 13, 2023Therapeutic or Diagnostic Output Failure

  BIOPINCE BIOSPY GUN RETURNED A GOOD INITIAL SAMPLE ON A PELVIC TRANSPLANTED KIDNEY BIOPSY, BUT SECOND AND THIRD PASSES WERE EMPTY. BARD BIOPSY DEVICE WAS USED TO ACHIEVE A SECOND SAMPLE. OTHER SURGEONS REPORTED SIMILAR PROBLEMS IN THE PAST COUPLE OF DAYS. CYTOLOGY TECH FOR TODAY'S CASE CONFIRMED THAT MANY PROVIDERS ARE HAVING THIS SAME ISSUE WITH THIS PARTICULAR BRAND OF BIOPSY DEVICE. I SUSPECT, BUT CANNOT CONFIRM, THAT THE PINCER MECHANISM IS MALFUNCTIONING AND NOT COMPLETELY SEVERING THE SAMPLE. MANUFACTURER RESPONSE FOR BIOPSY NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER). UNSUCCESSFUL ATTEMPT TO REACH OUT ARGON REP.

  Patient problems: Insufficient Information

  MAUDE report 16731815 ↗
• MalfunctionMar 15, 2023Output Problem

  AN ELDERLY MALE WITH NO SIGNIFICANT PAST MEDICAL HISTORY. UNDERWENT OUTPATIENT PROCEDURE FOR LEFT KIDNEY BIOPSY DUE TO PROTEINURIA. USING CT GUIDANCE, A 17-GAUGE COAXIAL NEEDLE WAS DIRECTED INTO LOWER POLE OF THE LEFT KIDNEY. THE 18-GAUGE BIOPSY NEEDLE WAS INSERTED COAXIALLY, AND 4 CORE BIOPSY SPECIMENS WERE OBTAINED. THE BIOPSY GUN WAS MALFUNCTIONING, WITH NO CORE OBTAINED DESPITE FIRING AND CAUSING A SMALL HEMATOMA. THE COAXIAL NEEDLE WAS THEN REMOVED AFTER INJECTION OF GELFOAM SLURRY AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. STERILE DRESSINGS WERE APPLIED. POST BIOPSY LIMITED CT SCAN SHOWED NO EVIDENCE OF HEMATOMA OR OTHER COMPLICATION.

  Patient problems: Hematoma

  MAUDE report 16544933 ↗
• DeathNov 29, 2022Firing Problem

  THE FOLLOWING REPORT WAS SENT TO ARGON BY THE HOSPITAL AND ALSO SENT TO FDA AND IS CITED AS FOLLOWS: ON (B)(6) 2022, PATIENT WENT TO INTERVENTIONAL RADIOLOGY FOR A LIVER BIOPSY USING THE BIOPINCE ULTRA 18G. POSTPROCEDURE, THE PATIENT DEVELOPED RESPIRATORY DISTRESS PROMPTING A CHEST ULTRASOUND WHICH SHOWED BLEEDING IN THE RIGHT CHEST. PIGTAIL PLACED FOR DRAINAGE; HOWEVER, BLEEDING PERSISTED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CHEST EXPLORATION. PATIENT FOUND TO HAVE A PUNCTURE SITE IN THE RIGHT LOWER LOBE WITH SIGNIFICANT AMOUNT OF BLOOD LOSS WITHIN THE CHEST. IT'S BELIEVED THAT THE DEVICE MISFIRED AT A LONGER DISTANCE THAN WHAT WAS SET.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Perforation; Respiratory Insufficiency

  MAUDE report 15878540 ↗
• MalfunctionJun 28, 2022Positioning Problem; Key or Button Unresponsive/not Working

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841359 ↗
• MalfunctionJun 16, 2021Defective Device

  DEVICE WAS PREPARED AT 3.3CM THROW. UPON ATTEMPTING TO TAKE A SAMPLE, NO TISSUE WAS OBTAINED. HOWEVER, BLOOD CAME FROM THE INTRODUCER INDICATING WE HAD PUNCTURED THE LIVER. TRIED AGAIN, AGAIN NO TISSUE. WE USED A NEW BIOPSY DEVICE AND GELFOAM FOR HEMOSTASIS.

  Patient problems: Internal Organ Perforation

  MAUDE report 12013476 ↗

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