BioPince™ Full Core Biopsy Instrument 360-1080-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00886333004379), received between Jun 17, 2020 and Sep 11, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 23, 2024Break; Break

  BREAKAGE OF A BIOPINCE BREAST BIOPSY NEEDLE DURING BIOPSY ON (B)(6) 2024 WITHOUT THIS BEING NOTICED BY THE DOCTOR. A METAL FRAGMENT REMAINED IN THE LEFT BREAST UNTIL 10 JUNE, WHEN IT WAS EXPELLED. THE DOCTOR CHECKED FOLLOWING REMOVAL WITH A MAMMOGRAM TO ENSURE THERE WAS NO METALLIC IN THE LEFT BREAST.

  Patient problems: Foreign Body In Patient

  MAUDE report 19812709 ↗
• InjuryJun 30, 2024Failure to Obtain Sample; Failure to Obtain Sample

  THE REPORTER INDICATED MULTIPLE BIOPINCE NEEDLES (18GA 10CM) WERE CATCHING SOFT TISSUE BETWEEN THE INNER STYLET AND THE OUTER SAMPLE CYLINDER PRIOR TO FIRING. THIS RESULTED IN INCOMPLETE SAMPLES, ABSENT SAMPLES, AND-IN THE FINAL CASE-A RENAL PSEUDOANEURYSM, THE PSEUDOANEURYSM OCCURRED WITHOUT THE NEEDLE BEING FIRED. WILL RETURN ALL UNITS WITH THIS LOT NUMBER DUE TO MULTIPLE OCCURRENCES. THIS REPORT IS FOR THE RENAL PSEUDOANEURYSM.

  Patient problems: Pseudoaneurysm

  MAUDE report 19641060 ↗
• InjuryMay 8, 2024Failure to Obtain Sample; Failure to Obtain Sample

  A CUSTOMER REPORTED MULTIPLE BIOPSY NEEDLES (18G 10 CM) AT LEAST 7 USED ON 5 SEPARATE PATIENTS WERE CATCHING SOFT TISSUE BETWEEN THE INNER STYLET AND THE OUTER SAMPLE CYLINDER PRIOR TO FIRING. THIS RESULTED IN INCOMPLETE SAMPLES ABSENT SAMPLE AND IN THE FINAL CASE A RENAL PSEDUOANEURYSM. THE PSEUDOANEURYSM OCCURRED WITHOUT THE NEEDLE BEING FIRED.

  Patient problems: Pseudoaneurysm

  MAUDE report 19274224 ↗
• InjuryApr 26, 2021Use of Device Problem

  THE HOSPITAL USES THE BIOPSY NEEDLE TO PUNCTURE THE LUNG FOR THE PATIENT. AFTER THE BIOPSY SAMPLE IS TAKEN, THE TISSUE IS PUSHED OUT FROM THE BIOPSY NEEDLE, THE TAIL OF THE BIOPSY GUN SPLITS AND AUTOMATICALLY TRIGGERS, RESULTING IN THE USER'S HAND STABBING.

  Patient problems: Laceration(s)

  MAUDE report 11725301 ↗
• MalfunctionMar 25, 2021Therapeutic or Diagnostic Output Failure

  I WAS TO PERFORM A CT GUIDED LUNG BIOPSY TO DIAGNOSE WHAT WAS ASSUMED TO BE A LUNG CANCER. AFTER PLACEMENT OF A COAXIAL NEEDLE INTO THE NODULE, THE FIRST TWO BIOPINCE NEEDLES YIELDED NO SAMPLE (THESE ARE THE NEEDLES THAT HAVE BEEN RETURNED). THIS LEAD TO A DELAY IN THE PROCEDURE DURING WHICH THE PATIENT DEVELOPED A PNEUMOTHORAX (COLLAPSED LUNG) AND THE COAXIAL NEEDLE POSITION WAS LOST. ALTHOUGH A COLLAPSED LUNG IS A RECOGNIZED COMPLICATION, THE DELAY IN THE PROCEDURE DUE TO EQUIPMENT FAILURE IS LIKELY TO HAVE SIGNIFICANTLY WORSENED THIS SITUATION. ALTHOUGH WE ATTEMPTED A THIRD SAMPLE WITH ANOTHER NEEDLE WHICH DID PROVIDE A SAMPLE, BY THIS POINT COAXIAL NEEDLE POSITION HAD BEEN LOST AND THE SAMPLE WAS NEGATIVE FOR CANCER (DUE TO INCORRECT NEEDLE POSITION). THE PATIENT ALSO NEEDED ADMITTED TO HOSPITAL FOR SEVERAL DAYS RATHER THAN BE DISCHARGED THAT AFTERNOON. IN SUMMARY, BIOPSY NEEDLE FAILURE X2 IS LIKELY TO HAVE BEEN A SIGNIFICANT CONTRIBUTOR TO LUNG COLLAPSE DEVELOPMENT AND NON-DIAGNOSTIC SAMPLE GIVEN THE TIME DELAY INTRODUCED.

  Patient problems: Pneumothorax

  MAUDE report 11572532 ↗
• MalfunctionDec 18, 2020Mechanical Problem

  THE DEVICE WAS FUNCTIONAL IN ITS FIRING MECHANISM HOWEVER DID NOT PULL A CORE OF THE LIVER TISSUE THE PHYSICIAN ATTEMPTED TWICE AND WITH NO RESULT OPTED TO OPEN A NEW DEVICE AS TO NOT PUT THE PATIENT AT INCREASED RISK FOR BLEEDING.

  Patient problems: Insufficient Information

  MAUDE report 11040344 ↗
• MalfunctionDec 5, 2020Use of Device Problem

  DR. (B)(6) DID A LIVER BX AND USED TWO BIOPSY GUNS WHERE NO SAMPLE WAS OBTAINED (JUST BLOOD). HE HAD TO USE A THIRD NEEDLE WITH A DIFFERENT LOT NUMBER AND FINALLY GOT SPECIMEN. SO INSTEAD OF THE USUAL 2-3 PASSES, HE ENDED UP DOING 7 PASSES IN A TRANSPLANT LIVER TO GET ENOUGH CORES TO SEND TO PATH. ANOTHER PHYSICIAN HAD ISSUES WITH IT THIS WEEKEND AS WELL AND ACCORDING TO THE OTHER PHYSICIANS THIS HAS HAPPENED TO THEM IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950930 ↗
• MalfunctionSep 10, 2020Use of Device Problem

  NUMBER OF PATIENT: 1. POSITION: PRONE. LESION LOCATION:APICAL SEGMENT (S I) OF RIGHT LUNG. LESION SIZE:= 1.0 CM. TECHNIQUE: CO-AXIAL (MCXS1810BP). RESULT: INCOMPLETE SAMPLE (EMPTY GUN). COMPLICATION: PARENCHYMAL HEMORRHAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10515414 ↗
• MalfunctionAug 3, 2020Break; Deformation Due to Compressive Stress

  FOLLOW UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359957 ↗
• MalfunctionJul 3, 2020Break

  THE COMPLAINT DESCRIPTION ONLY INDICATES "BLADE UP". THE RETURNED SAMPLE TO ARGON FOUND THAT THE PINCER HAD BROKEN OFF FROM THE DEVICE. IT IS POSSIBLE THAT THE MISSING PIECE HAD TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10227725 ↗
• MalfunctionJun 17, 2020Adverse Event Without Identified Device or Use Problem

  APPLICATION/PROCEDURE: BIOPSY SOFT TISSUE / BREAST. PROCESS/PRODUCT GROUP: BIOPINCE TO TAKE A BREAST BIOPSY. COMPLAINT SITUATION: LAST WEEK (WEEK FROM (B)(6) 2020) A WOMAN WITH BREAST CANCER HAD A BIOPSY, AND THE NEXT DAY IN THE MRI SCAN. A BREAST PHOTO WAS TAKEN YESTERDAY (MONDAY (B)(6) 2020) AND THEN THEY SAW THE PIECE OF METAL, ALSO LATER ON THE MRI SCAN. HER BREAST WILL BE AMPUTATED AFTER THE IRRADIATION AND THEN OUR REQUEST WAS TO KEEP THAT METAL PIECE IN DUE TIME. SO THAT WE CAN SEND THIS TO ARGON FOR INVESTIGATION. THE BREAST WILL BE AMPUTATED IN THE COMING PERIOD, AFTER THAT THEY WILL TAKE OUT THE METAL PIECE AND KEEP IT FOR US. SO THAT IT CAN BE SENT TO ARGON. THE COMPLAINT WAS ALREADY INTERNALLY REGISTERED UNDER NO. (B)(4) BY THE QUALITY DEPARTMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10165242 ↗

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