BioPince™ Full Core Biopsy Instrument 370-1580-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886333004362), received between Aug 6, 2020 and Dec 12, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryDec 5, 2022Defective Device

  WHEN THE PATIENT WAS PERFORMING LIVER PUNCTURE UNDER THE GUIDANCE OF B-ULTRASOUND, THE BIOPSY NEEDLE WAS USED. NO TISSUE WAS TAKEN FROM THE PUNCTURE TWICE, ONLY BLOOD. LATER, THE PUNCTURE NEEDLE OF OTHER PRODUCTS WAS REPLACED SUCCESSFULLY. THE DOCTOR BELIEVED THAT THE CONDITION PROLONGED THE OPERATION TIME AND CAUSED SECONDARY INJURY TO THE PATIENT, SO HE REPORTED THE INCIDENT TO THE COMPETENT AUTHORITY.

  Patient problems: Insufficient Information

  MAUDE report 15916614 ↗
• MalfunctionNov 17, 2022Difficult to Remove; Therapeutic or Diagnostic Output Failure

  EMPTY SAMPLE. NO SAMPLE WHEN THE BIOTWEEZER IS REMOVED. DIFFICULTY REMOVING THE BIOWEEZER FROM THE COAXIAL SHEATH. NEED TO REPEAT A NEW BIOPSY INCREASING THE RISK OF BLEEDING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15812137 ↗
• MalfunctionJun 9, 2022Therapeutic or Diagnostic Output Failure

  THE TISSUE COULD NOT BE TAKEN OUT; THIS INCIDENT WAS USED WITH A COAXIAL GUIDE NEEDLE. THE GUN WAS NOT TESTED BEFORE USE. WHEN THE INSTRUMENT WAS TAKEN OUT, IT WAS ROTATED 360 DEGREES. THE RANGE OF USE WAS 23MM. THE EMPTY GUN OCCURRED AT THE FIRST NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643373 ↗
• MalfunctionMay 6, 2022Mechanical Problem

  THE PATIENT UNDERWENT A LUNG BIOPSY WITH 5 PUNCTURES WITH A BIOPSY NEEDLE, BUT NO TISSUE WAS REMOVED. CHANGED A GUN AND DIDN'T REMOVE THE TISSUE. WHEN THE THIRD GUN WAS USED, THE TISSUE WAS SUCCESSFULLY REMOVED. ; THIS INCIDENT IS USED TOGETHER WITH THE COAXIAL GUIDE NEEDLE. THE GUN HAS BEEN TESTED BEFORE USE. WHEN THE INSTRUMENT IS TAKEN OUT, IT IS ROTATED 360 DEGREES. THE RANGE OF USE IS 23MM. THE EMPTY GUN OCCURS AT THE FIRST NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 14304711 ↗
• InjuryJul 21, 2021Break

  RENAL PUNCTURE WAS PERFORMED IN THREE PATIENTS, AND BLEEDING OCCURRED IN TWO PATIENTS; ANOTHER PATIENT WAS UNABLE TO TAKE OUT THE TISSUE AT THE FIRST PUNCTURE, AND THE NEEDLE IS DAMAGED. FOUR BP WERE REPLACED CONTINUOUSLY. AT THE FIFTH PUNCTURE, A LARGE AMOUNT OF BLEEDING AND NECROSIS OF THE RIGHT KIDNEY OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 12205020 ↗
• MalfunctionFeb 24, 2021Defective Device

  DURING THE BIOPSY ON MASS FRAGMENTS OF THE RECTUS MUSCLES OF A PATIENT NO SAMPLE WAS TAKEN AFTER 3 ATTEMPTS.

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

  MAUDE report 11376791 ↗
• MalfunctionFeb 17, 2021Therapeutic or Diagnostic Output Failure

  BIOPINCE: 16GX15CM WAS USED FOR LUNG BIOPSY AND THE DEVICE DIDN¿T FETCH ANY SAMPLE EVEN AFTER MULTIPLE FIRING. DOCTOR USED BARD BIOPSY GUN AND IT FETCHED SAMPLE .

  Patient problems: Insufficient Information

  MAUDE report 11340862 ↗
• MalfunctionAug 6, 2020Scratched Material

  FOLLOW UP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 10376905 ↗

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