BioPince™ Full Core Biopsy Instrument 360-1580-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00886333004355), received between May 3, 2018 and Jan 23, 2026 — classified as 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE REPORTER INDICATED THE BIOPSY NEEDLE'S OUTER SHEATH FELL OFF, AND THE NEEDLE ALMOST PENETRATED THE HEART. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199143 ↗
• InjuryApr 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A FOLLOW-UP CHEST CT SCAN SHOWED SLIGHT PULMONARY BLEEDING AND MODERATE PNEUMOTHORAX AROUND THE PUNCTURE SITE. A GUIDE WIRE WAS INSERTED ALONG THE ELECTROMAGNETIC NAVIGATION PUNCTURE NEEDLE, THE SKIN OPENING WAS DILATED, AND A THORACIC PUNCTURE TUBE WAS INSERTED ALONG THE GUIDE WIRE. A FIXED PUNCTURE TUBE WITH A DEPTH OF 15CM WAS LEFT IN THE CHEST CAVITY, AND AN EXTERNAL DRAINAGE BUCKET WAS CONNECTED. A MODERATE AMOUNT OF GAS WAS EXTRACTED, AND STERILE DRESSING WAS USED FOR DRESSING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 19198920 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISPOSABLE BIOPSY NEEDLE WAS USED TO PUNCTURE A SPACE OCCUPYING LESION IN THE LOWER LOBE OF THE LEFT LUNG, AND THERE WAS SLIGHT BLEEDING IN THE LUNG WITHOUT SPECIAL TREATMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18744133 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A FOLLOW-UP EXAMINATION OF THE CHEST AFTER PUNCTURE REVEALED A SMALL AMOUNT OF NEEDLE BLEEDING AND MODERATE PNEUMOTHORAX. SUBSEQUENTLY, A PUNCTURE TUBE ASPIRATION SURGERY WAS PERFORMED, WITH APPROXIMATELY 1000ML OF GAS EXTRACTED. THE PATIENT'S SUFFOCATION WAS RELIEVED, AND A CLOSED THORACIC DRAINAGE TUBE WAS CONNECTED.

  Patient problems: Pneumothorax

  MAUDE report 18333104 ↗
• MalfunctionJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE PATIENT USES A DISPOSABLE BIOPSY NEEDLE FOR PUNCTURE IN THE CT ROOM, THE BIOPSY TISSUE IS TAKEN OUT. UNDER CT, BLEEDING IS FOUND IN THE PATIENT'S LUNG PARENCHYMA, WHICH DOES NOT REQUIRE SPECIAL TREATMENT AND CAN BE ABSORBED ON ITS OWN. AFTER THE SURGERY, THE PATIENT SHOWED NO OBVIOUS DISCOMFORT AND ALL INDICATORS OF ELECTROCARDIOGRAM MONITORING WERE NORMAL. THEY WERE ESCORTED BACK TO THE WARD AND GIVEN ELECTROCARDIOGRAM MONITORING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17079175 ↗
• MalfunctionJun 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  WHEN THE PATIENT USES A DISPOSABLE BIOPSY NEEDLE FOR PUNCTURE IN THE CT ROOM, THE BIOPSY TISSUE IS TAKEN OUT. UNDER CT, BLEEDING IS FOUND IN THE PATIENT'S LUNG PARENCHYMA, WHICH DOES NOT REQUIRE SPECIAL TREATMENT AND CAN BE ABSORBED ON ITS OWN. AFTER THE SURGERY, THE PATIENT SHOWED NO OBVIOUS DISCOMFORT AND ALL INDICATORS OF ELECTROCARDIOGRAM MONITORING WERE NORMAL. THEY WERE ESCORTED BACK TO THE WARD AND GIVEN ELECTROCARDIOGRAM MONITORING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17059296 ↗
• MalfunctionNov 17, 2022Failure to Obtain Sample

  FOLLOWING SEVERAL PUNCTURES , NO SAMPLES RETAINED. THE PATIENT MUST BE REPUNCTURED SEVERAL TIMES IN THE LIVER. HEMORRHAGIC RISK.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 15812169 ↗
• InjuryMay 16, 2022Improper or Incorrect Procedure or Method

  PERFORM RENAL BIOPSY ON THE PATIENT, CUT THE KIDNEY TISSUE 4 TIMES, THE BIOPSY NEEDLE CAN ONLY TAKE OUT A VERY SMALL AMOUNT OF TISSUE; THIS INCIDENT WAS NOT USED WITH A COAXIAL GUIDE NEEDLE, THE GUN WAS NOT TESTED BEFORE USE, AND THE INSTRUMENT WAS TAKEN OUT WITHOUT 360-DEGREE ROTATION. THE FIRING RANGE IS 23MM, AND THE EMPTY GUN OCCURS IN THE 1ST SHOT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14407178 ↗
• InjuryJan 17, 2022Difficult to Remove; Material Deformation; Mechanical Jam

  THE NEEDLE OF THE BIOPSY NEEDLE WAS DEFORMED, AND IT WAS STUCK IN THE BODY AFTER FIRING AND COULD NOT BE TAKEN OUT. FINALLY, IT WAS TAKEN OUT TOGETHER WITH THE CO-AXIAL INTRODUCER NEEDLES, CAUSING THE PATIENT TO BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13266118 ↗
• MalfunctionFeb 24, 2021Break

  FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376195 ↗
• MalfunctionFeb 12, 2021Firing Problem

  PROCEDURE DONE UNDER US GUIDANCE NON CO-AXIAL. FIRST FIRE NO TISSUE. PHYSICIAN GRABBED SECOND BIOPINC FIRED, NO TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324775 ↗
• MalfunctionFeb 10, 2021Break

  THE NEEDLE WAS BROKEN INSIDE, THE NEEDLE WAS LEFT IN THE DEVICE WHEN TRIGGERED IT. IT IS VERY DANGEROUS. THE EVENT WAS FOUND AFTER IT WAS USED ON THE PATIENT, BUT IT DID NOT BREAK OFF INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11310947 ↗
• MalfunctionSep 10, 2020Failure to Obtain Sample

  FOLLOW UP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 10515066 ↗
• MalfunctionSep 7, 2018Break

  THE PATIENT WAS HERE FOR A LIVER BIOPSY. THE DOCTOR FIRED THE BIOPENCE GUN TO TEST IT AND IT CAME APART. BIOPSY COMPLETED WITH ANOTHER BIOPENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854795 ↗
• MalfunctionMay 3, 2018Material Fragmentation

  THE PATIENT WAS UNDERGOING A RENAL BIOPSY AND AFTER THE FIRST FIRING THERE WERE TWO PIECES OF METAL EXPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482741 ↗
• MalfunctionMay 3, 2018Device Operates Differently Than Expected

  TWO PATIENTS UNDERGOING DIFFERENT PROCEDURES (MEDICAL LIVER BIOPSY AND KIDNEY BIOPSY) WITH THE SAME PRODUCT FAILURE. IN EACH INSTANCE, THE DEVICE FAILED TO FUNCTION PROPERLY RESULTING IN NO SPECIMEN BEING ACQUIRED. THE DEVICES SHARED THE SAME LOT AND EXPIRATION DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482728 ↗

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