BioPince Full Core Biopsy InstrumentRecalls & reported problems across all models

We found 5 models of BioPince Full Core Biopsy Instrument by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between May 3, 2018 and Jan 23, 2026 — classified as 23 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 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 5 of these models · Recall details · FDA record ↗

Most reported BioPince Full Core Biopsy Instrument problems

BioPince Full Core Biopsy Instrument models

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

• BioPince™ Full Core Biopsy Instrument 360-1580-01

  Instrument, Biopsy
  1 recall25 reports
• BioPince™ Full Core Biopsy Instrument 360-1080-01

  Instrument, Biopsy
  1 recall13 reports
• BioPince™ Full Core Biopsy Instrument 370-1580-01

  Instrument, Biopsy
  1 recall10 reports
• BioPince™ Full Core Biopsy Instrument 360-2080-01

  Instrument, Biopsy
  1 recall6 reports
• BioPince™ Full Core Biopsy Instrument 370-1080-01

  Instrument, Biopsy
  1 recall6 reports

Recent BioPince 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.

• InjuryJan 23, 2026Break

  THE NEPHROLOGY DEPARTMENT OF THE HOSPITAL USED A DISPOSABLE BIOPSY NEEDLE TO PERFORM A PUNCTURE ON A PATIENT. THE NEEDLE TIP BROKE. THIS CAUSED VERY SERIOUS CONSEQUENCES FOR THE DIRECTOR AND THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24172926 ↗
• InjuryJan 1, 2026Break

  THE NEPHROLOGY DEPARTMENT OF THE HOSPITAL USED A DISPOSABLE BIOPSY NEEDLE TO PERFORM A LIVER PUNCTURE ON THE PATIENT. THE NEEDLE TIP BROKE, CAUSING SERIOUS SURGICAL DIFFICULTIES FOR THE OPERATION SUPERVISOR.

  Patient problems: Insufficient Information

  MAUDE report 23939686 ↗
• InjuryDec 20, 2025Break; Break

  ON (B)(6) 2025, THE DEPARTMENT OF NEPHROLOGY OF (B)(6). USED A DISPOSABLE BIOPSY NEEDLE TO PERFORM A LIVER PUNCTURE ON A PATIENT. THE NEEDLE TIP BROKE, CAUSING SERIOUS SURGICAL DIFFICULTIES FOR THE OPERATION SUPERVISOR. PLEASE HANDLE IT AS SOON AS POSSIBLE. THIS PATIENT IS A LIVER CANCER PATIENT AND THE GOODS CANNOT BE MAILED.

  Patient problems: Pneumothorax

  MAUDE report 23860038 ↗
• MalfunctionOct 22, 2025Break; Break

  ON (B)(6) 2025, THE RENAL DEPARTMENT OF THE HOSPITAL USED A DISPOSABLE BIOPSY NEEDLE TO PERFORM A LIVER PUNCTURE ON A PATIENT. THE NEEDLE TIP BROKE, AND THEY TOOK ANOTHER ONE, BUT THE NEEDLE TIP STILL BROKE. THE PATIENT EXPERIENCED THE PAIN TWICE, AND IT ALSO CAUSED SERIOUS SURGICAL DIFFICULTIES FOR THE OPERATION SUPERVISOR. PLEASE HANDLE IT AS SOON AS POSSIBLE.

  Patient problems: Pain

  MAUDE report 23359704 ↗
• MalfunctionSep 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REPORTER INDICATED "THE PATIENT WAS ADMITTED DUE TO "LOWER BACK PAIN ACCOMPANIED BY WEAKNESS IN BOTH LOWER LIMBS FOR 3 YEARS, WORSENING FOR 3 DAYS." CT SCAN ON (B)(6)2025 SHOWED A MASS IN THE UPPER LOBE OF THE LEFT LUNG, SUGGESTING A HIGH POSSIBILITY OF MALIGNANT LESIONS. FURTHER EXAMINATION IS RECOMMENDED. THE POSSIBILITY OF MALIGNANCY CANNOT BE RULED OUT IN THE PATIENT'S LUNG SPACE OCCUPYING LESIONS. AFTER SIGNING THE INFORMED CONSENT FORM, PERCUTANEOUS LUNG BIOPSY WAS PERFORMED UNDER CT GUIDANCE. AFTER CT POSITIONING, LOCAL DISINFECTION WAS PERFORMED, AND 5% LIDOCAINE WAS USED TO INFILTRATE AND ANESTHETIZE THE PLEURA LAYER BY LAYER ALONG THE POSITIONING POINT. AFTER THE COAXIAL GUIDE NEEDLE WAS INSERTED 2.5CM, THE CT POSITIONING INDICATED THAT THE NEEDLE TIP HAD REACHED THE EDGE OF THE PLEURAL LESION. THE NEEDLE CENTER WAS REMOVED, AND THE DEPTH OF THE DISPOSABLE BIOPSY NEEDLE WAS ADJUSTED TO 23MM. TWO NEEDLE BIOPSIES WERE PERFORMED, AND CORD LIKE TISSUE WAS VISIBLE. AFTER FIXING WITH SPECIMEN SOLUTION, THE PATIENT WAS SENT TO THE PATHOLOGY DEPARTMENT. AFTER REMOVING THE COAXIAL GUIDE NEEDLE AND PERFORMING LOCAL DISINFECTION AND BANDAGING, A CHEST CT SCAN SHOWED NO OBVIOUS PNEUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027936 ↗
• InjuryJul 2, 2025Failure to Obtain Sample; Failure to Obtain Sample

  CUSTOMER REPORTED "ON (B)(6) 2025, DURING PERCUTANEOUS LUNG PUNCTURE, THERE WAS NO RESPONSE TO THE DISPOSABLE BIOPSY NEEDLE SHRAPNEL. ONE NEEDLE WAS IMMEDIATELY REPLACED, RESULTING IN PROLONGED OPERATION TIME AND SYMPTOMS OF SHORTNESS OF BREATH AND SUFFOCATION IN THE PATIENT. CT SHOWED PNEUMOTHORAX. IMMEDIATE CLOSED CHEST DRAINAGE WAS PERFORMED, AND THE PATIENT'S SYMPTOMS WERE RELIEVED."

  Patient problems: Dyspnea; Pneumothorax

  MAUDE report 22384424 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  A CUSTOMER REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, AFTER PUNCTURE, IT WAS FOUND THAT THE NEEDLE TIP WAS DAMAGED, AND THE PATIENT FELT STRONG PAIN. THERE WAS NO PATIENT HARM.

  Patient problems: Pain

  MAUDE report 22307765 ↗
• 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 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A SMALL AMOUNT OF BLEEDING DURING THE OPERATION, AND SYMPTOMATIC HEMOSTATIC TREATMENT WAS GIVEN. AFTER RE EXAMINATION OF CT, NO CLEAR BLEEDING WAS FOUND. DURING THE PUNCTURE PROCESS, A FOLLOW-UP CT SCAN SHOWED A SMALL AMOUNT OF PNEUMOTHORAX ON THE LEFT SIDE. THE HOSPITAL REPORTED THIS CASE TO NMPA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20915346 ↗
• 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 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER TAKING LIVER TISSUE, IT WAS FOUND THAT THE TISSUE WAS NOT COMPLETELY REMOVED POSTOPERATIVE OBSERVATION SHOWS THAT THE DETACHMENT FRAGMENT AT THE PUNCTURE NEEDLE SITE IS BROKEN, AND THE PATIENT EXPERIENCES SIGNIFICANT PAIN DURING AND AFTER THE OPERATION.

  Patient problems: Pain

  MAUDE report 20765542 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT CT GUIDED PUNCTURE BIOPSY OF A MASS IN THE MIDDLE LOBE OF THE RIGHT LUNG. POSTOPERATIVE FOLLOW-UP CT SHOWED A SMALL AMOUNT OF PNEUMOTHORAX. THE PATIENT WAS OBSERVED TO HAVE NO CHEST TIGHTNESS OR SHORTNESS OF BREATH AND SAFELY RETURNED TO THE WARD. ON THE DAY AFTER SURGERY, THE RIGHT CHEST BECAME MORE SUFFOCATING THAN BEFORE, AND THE CHEST PAIN WORSENED AT NIGHT. UPON RE EXAMINATION OF THE CHEST X-RAY, THE AMOUNT OF PNEUMOTHORAX INCREASED. A CLOSED DRAINAGE SURGERY WAS PERFORMED ON THE RIGHT CHEST, AND A LARGE AMOUNT OF GAS WAS INTRODUCED THROUGH THE PLACEMENT OF A CHEST DRAINAGE TUBE. THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT DISCOMFORT AFTER THE SURGERY.

  Patient problems: Pneumothorax

  MAUDE report 20652668 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATE, "THE PATIENT UNDERWENT CT GUIDED RIGHT LUNG BIOPSY SURGERY, AND 3 BIOPSIES WERE TAKEN. THE PATIENT DEVELOPED HEMOPTYSIS, AND CT RE EXAMINATION SHOWED SIGNIFICANT PNEUMOTHORAX."

  Patient problems: Hemoptysis; Pneumothorax

  MAUDE report 20252423 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED "THE PATIENT UNDERWENT CT GUIDED RIGHT LUNG BIOPSY SURGERY, AND 3 BIOPSIES WERE TAKEN. THE PATIENT DEVELOPED HEMOPTYSIS, AND CT RE EXAMINATION SHOWED SIGNIFICANT PNEUMOTHORAX."

  Patient problems: Hemoptysis; Pneumothorax

  MAUDE report 20252284 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED "THE PATIENT UNDERWENT A CT GUIDED RIGHT UPPER LUNG MASS BIOPSY SURGERY. AFTER THE SURGERY, A CHEST CT WAS RECHECKED, AND THERE WAS A SMALL AMOUNT OF PNEUMOTHORAX ON THE RIGHT SIDE. AFTER RETURNING TO THE WARD, THE AMOUNT OF PNEUMOTHORAX ON THE RIGHT SIDE INCREASED. THE PATIENT WAS GIVEN A THORACENTESIS TUBE DRAINAGE TO EXTRACT A MODERATE AMOUNT OF GAS. THE PATIENT EXPERIENCED CHEST TIGHTNESS AND WAS GIVEN INTRAVENOUS INFUSION OF METHYLPREDNISOLONE, WHICH RELIEVED THE SYMPTOMS."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax

  MAUDE report 20250666 ↗

Other Argon Medical Devices, Inc. products

• First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
• BioPince Ultra Full Core Biopsy Instrument10 models · 85 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