BioPince Ultra Full Core Biopsy InstrumentRecalls & reported problems across all models

We found 10 models of BioPince Ultra Full Core Biopsy Instrument by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2020 and Sep 25, 2026 — classified as 2 deaths, 16 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (24 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BioPince Ultra Full Core Biopsy Instrument recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 10 of these models · Recall details · FDA record ↗

Most reported BioPince Ultra Full Core Biopsy Instrument problems

BioPince Ultra Full Core Biopsy Instrument models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BioPince Ultra Full Core Biopsy Instrument 360-1080-02

  Instrument, Biopsy
  1 recall27 reports
• BioPince Ultra Full Core Biopsy Instrument 360-1080-03

  Instrument, Biopsy
  1 recall2 deaths15 reports
• BioPince Ultra Full Core Biopsy Instrument 360-2080-02

  Instrument, Biopsy
  1 recall13 reports
• BioPince™ Ultra Full Core Biopsy Instrument 370-1080-02

  Instrument, Biopsy
  1 recall12 reports
• BioPince Ultra Full Core Biopsy Instrument 360-1580-03

  Instrument, Biopsy
  1 recall7 reports
• BioPince Ultra Full Core Biopsy Instrument 360-1580-02

  Instrument, Biopsy
  1 recall6 reports
• BioPince™ Ultra Full Core Biopsy Instrument 370-1580-02

  Instrument, Biopsy
  1 recall3 reports
• BioPince Ultra Full Core Biopsy Instrument 360-2080-03

  Instrument, Biopsy
  1 recall1 report
• BioPince™ Ultra Full Core Biopsy Instrument 370-1080-03

  Instrument, Biopsy
  1 recall1 report
• BioPince™ Ultra Full Core Biopsy Instrument 370-1580-03

  Instrument, Biopsy
  1 recall0 reports

Recent BioPince Ultra Full Core Biopsy Instrument adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Liver biopsy to investigate histological changes consistent with immunotherapy-associated hepatitis. Loading/tensioning the Biopince was somewhat difficult but feasible (this issue occurs with nearly all Biopince biopsy needles). Dry firing/triggering was possible without any problems. Re-tensioning is possible. Sample collection with normal visibility on ultrasound. The punch cylinder should then be ejected. The tensioning required for ejection is very difficult but ultimately possible. During ejection, a small gray piece (presumably from inside the Biopince) breaks off and falls onto the sterile table. If the Biopince could not have been clamped open, the sample could not have been ejected and analyzed. In that case, a repeat biopsy would have been necessary. This would have carried an increased risk of bleeding, etc., since the first biopsy was performed without an over-needle closure technique, based on the assumption that only a single sample collection was necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893144 ↗
• MalfunctionJan 29, 2026Failure to Obtain Sample

  A CUSTOMER REPORTED A PHYSICIAN WAS PERFORMING RENAL BIOPSY AND THE DEVICE WAS FIRING BUT NOT COLLECTING SAMPLES AFTER THE FIRST PASS. 1 OF THE 10 PASSES ATTEMPTED ONLY COLLECTED A SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218109 ↗
• MalfunctionNov 5, 2025Break; Break

  A CUSTOMER REPORTED "ONE OF OUR 16GA CORE BIOPSY GUNS BROKE WHEN DR WAS USING IT. WE FIRED IT A COUPLE TIMES WITH NO ISSUES AND THEN AFTER THE 3RD FIRE WHEN SHE PULLED IT OUT THE TIP OF THE INSTRUMENT WAS BUSTED OPEN." SAMPLE AND IMAGE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23478904 ↗
• InjuryJun 16, 2025Break; Break

  CUSTOMER REPORTED "THE INTRODUCER OF THE BPU BROKE OFF INSIDE THE PATIENT WHEN IT WAS BEING ADVANCED. ENDED UP HAVING A SURGEON REMOVE IT."

  Patient problems: Insufficient Information

  MAUDE report 22211685 ↗
• MalfunctionMay 19, 2025Misfire; Misfire

  A RADIOLOGIST ATTEMPTED TO USE THE SIDE BUTTON TO FIRE THE DEVICE DURING A RENAL BIOPSY. THE SIDE BUTTON FAILED; THE PHYSICIAN THEN ADJUSTED HIS HAND TO USE THE TRIGGER AT THE BACK OF THE NEEDLE AND THE DEVICE DEPLOYED WITHOUT ANY BUTTONS BEING PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047245 ↗
• MalfunctionApr 1, 2025Misfire; Misfire

  A LEAD CT TECH REPORTED THE DEVICE DISCHARGED WITHOUT BEING FIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741246 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 4, 2024Firing Problem; Firing Problem

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

  Patient problems: Insufficient Information

  MAUDE report 20850085 ↗
• 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 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 ↗
• 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 ↗

Other Argon Medical Devices, Inc. products

• First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
• BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
• L-Cath PICC S/L2 models · 30 reports · 1 recall
• Tru-Core II Biopsy Instrument8 models · 13 reports · 1 recall
• Scorpion2 models · 7 reports · 1 recall
• Arterial Line Kit2 models · 2 reports · 1 recall
• Tru-Core II URO Biopsy Instrument2 models · 2 reports · 1 recall
• Transvenous Pacing Electrode Tray2 models · 0 reports · 1 recall