MAX-CORE MC1825Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00801741084492), received between Nov 4, 2016 and Sep 30, 2026 — classified as 4 injuries, 280 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (126 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 25, 2019Terminated

   During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

   Z-0724-2020 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire; Activation Problem

  BARD MAX-CORE Disposable Core Biopsy Instrument did not fire currently when trigger was pressed, only 1/2 mechanisms activated.LOT: RELQ4188.REF: MC1825.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944753 ↗
• MalfunctionSep 23, 2026Failure to Fire

  On (b)(6) 2026, a patient underwent a kidney biopsy procedure using a Maxcore instrument. During the procedure, the cannula failed to retract automatically, making it impossible to obtain a tissue sample. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868110 ↗
• MalfunctionJul 29, 2026Misfire; Failure to Obtain Sample; Therapeutic or Diagnostic Output Failure

  During case biopsy gun was misfiring and failing to collect needed biopsies. Device was removed and replaced with a new one, case resumed without further complications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068668 ↗
• MalfunctionJun 25, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, WHEN THE DEVICE WAS FIRED FOR TISSUE EXTRACTION, THE DEVICE TIP BROKE OFF AND THE DEVICE WAS SUBSEQUENTLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617401 ↗
• MalfunctionJun 18, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, AFTER PRESSING THE BUTTON TO INSERT THE NEEDLE, THE INTRODUCER NEEDLE PRODUCED AN ABNORMAL SOUND AND FAILED TO PUNCTURE THE TISSUE. THE USER ATTEMPTED THE PROCEDURE THREE TIMES, BUT NO SPECIMEN COULD BE OBTAINED. THE INTRODUCER NEEDLE WAS IMMEDIATELY EXCHANGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547013 ↗
• MalfunctionJun 4, 2026Break; Failure to Obtain Sample

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ECHO GUIDED PROSTATE BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY MADE AN ABNORMAL SOUND OR MINIMAL TO NO SAMPLE WAS OBTAINED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387028 ↗
• MalfunctionJun 1, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT MICROWAVE ABLATION OF UTERINE FIBROIDS IN THE HYSTEROSCOPIC OPERATING ROOM. DURING THE INTRAOPERATIVE BIOPSY OF THE MASS, WHEN THE BIOPSY GUN WAS ACTIVATED, ONLY ONE OF THE TWO SEQUENTIAL FIRING BUTTONS PROPERLY REBOUNDED, WHICH RESULTED IN TWO CONSECUTIVE FAILURES TO OBTAIN ADEQUATE PATHOLOGICAL TISSUE SAMPLES, NECESSITATING MULTIPLE ADDITIONAL PUNCTURE BIOPSY ATTEMPTS FOR THE PATIENT TO ACHIEVE A SUCCESSFUL SAMPLE COLLECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353105 ↗
• MalfunctionMay 27, 2026Break

  ON (B)(6) 2026, A 74-YEAR-OD MALE PATIENT UNDERWENT A PROSTATE BIOPSY PROCEDURE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296301 ↗
• MalfunctionMay 4, 2026

  DURING PROSTATE BIOPSY THE BARD MAX CORE BIOPSY INSTRUMENT WOULD NOT ENGAGE THE BIOPSY NEEDLE TO RETRIEVE PROSTATE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067531 ↗
• MalfunctionApr 28, 2026

  BARD MAX CORE DISPOSABLE CORE BIOPSY INSTRUMENT DID NOT RETRIEVE AN ADEQUATE AMOUNT OF PROSTATE TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25014740 ↗
• MalfunctionApr 7, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT A SONOGRAPHIC GUIDED KIDNEY BIOPSY PROCEDURE BY USING MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE WAS ALLEGEDLY FAILED TO FIRE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801202 ↗
• MalfunctionMar 31, 2026

  PREPPED THE BIOPSY NEEDLE WE DISCOVERED IT WAS MISFIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741575 ↗
• MalfunctionMar 24, 2026Self-Activation or Keying

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY AUTO FIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679725 ↗
• MalfunctionMar 24, 2026Self-Activation or Keying

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY AUTO FIRED SINCE THE MECHANISM THAT PRESS THE BUTTON, DOES NOT WORKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679680 ↗
• MalfunctionMar 24, 2026Self-Activation or Keying

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY AUTO FIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672815 ↗
• MalfunctionMar 17, 2026Failure to Fire

  ON (B)(6), A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE BY USING A MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTER CANNULA OF THE INSTRUMENT ALLEGEDLY COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616056 ↗
• MalfunctionMar 17, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE BY USING A MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTER CANNULA OF THE INSTRUMENT ALLEGEDLY COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616052 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 8 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603771 ↗
• MalfunctionMar 16, 2026Break

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 10 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603770 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 7 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603768 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 5 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603767 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 9 OF 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603765 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 6 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603764 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 4 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603763 ↗
• MalfunctionMar 16, 2026Break; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS TRIGGERED, BUT THE BIOPSY NEEDLE DID NOT TAKE A SAMPLE AND SOUNDS ALMOST LIKE THE SPRING WOULD SNAP/BREAK. THERE WAS NO PATIENT REPORTED INJURY. THIS IS REPORT 3 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603762 ↗