MAX-CORE MC1810Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00801741084461), received between Oct 27, 2017 and Mar 11, 2026 — classified as 2 injuries, 174 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (97 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 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Failure to Fire

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE WAS UNABLE TO FIRE. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574073 ↗
• MalfunctionFeb 26, 2026Failure to Fire

  A PATIENT UNDERWENT ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO FIRE. THE DEVICE WAS PRIMED AS NORMAL HOWEVER, WHEN THEY ATTEMPTED TO FIRE IT USING THE BOTTOM TRIGGER FIRST, IT WAS FAILED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451545 ↗
• MalfunctionFeb 26, 2026Failure to Fire

  A PATIENT UNDERWENT ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO FIRE. THE DEVICE WAS PRIMED AS NORMAL HOWEVER, WHEN THEY ATTEMPTED TO FIRE IT USING THE BOTTOM TRIGGER FIRST, IT WAS FAILED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451543 ↗
• MalfunctionFeb 26, 2026Failure to Fire

  A PATIENT UNDERWENT ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO FIRE. THE DEVICE WAS PRIMED AS NORMAL HOWEVER, WHEN THEY ATTEMPTED TO FIRE IT USING THE BOTTOM TRIGGER FIRST, IT WAS FAILED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451542 ↗
• MalfunctionFeb 26, 2026Failure to Fire

  A PATIENT UNDERWENT ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO FIRE. THE DEVICE WAS PRIMED AS NORMAL HOWEVER, WHEN THEY ATTEMPTED TO FIRE IT USING THE BOTTOM TRIGGER FIRST, IT WAS FAILED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451541 ↗
• MalfunctionJan 22, 2026Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LYMPH BIOPSY THROUGH HARD DENSITY TISSUE USING A MAXCORE DEVICE. DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142188 ↗
• MalfunctionJan 22, 2026Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LYMPH BIOPSY THROUGH HARD DENSITY TISSUE USING A MAXCORE DEVICE. DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142186 ↗
• MalfunctionDec 4, 2025Failure to Fire; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE OUTER CANNULA CAN'T BE FIRED. NO COAXIAL WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713312 ↗
• MalfunctionOct 15, 2025Failure to Obtain Sample; Failure to Fire; Failure to Obtain Sample; Failure to Fire

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BIOPSY THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OBTAIN THE CORE IN SAMPLE NOTCH AND ITS VERY HARD TO RELEASE BOTH THE STYLET AND CANNULA OF THE DEVICE. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277186 ↗
• InjurySep 5, 2025Self-Activation or Keying; Self-Activation or Keying

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE. DURING THE PROCEDURE, THE DEVICE NEEDLE OPENED ITS NOTCH INSIDE THE PATIENT. FURTHER IT WAS REPORTED PATIENT WAS HOSPITALIZED AND ADMITTED FOR BLEEDING. CURRENT PATIENT STATUS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22976079 ↗
• MalfunctionJun 26, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE WITH THE MAXCORE DEVICE. PRIOR TO THE PROCEDURE IT CAME TO NOTICE THAT THERE WAS NO BATCH OR EXPIRY DATE STICKER OR DETAIL ON THE BIOPSY GUN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334744 ↗
• MalfunctionMay 9, 2025Failure to Fire; Failure to Fire

  ON (B)(6) 2025, DURING A RENAL BIOPSY PROCEDURE USING A MAXCORE DEVICE, UPON FIRING AND REMOVING THE NEEDLE, THE INNER TROCAR ADVANCED WHILE THE OUTER CUTTING CANNULA NOT ADVANCED AND PREVENTING SUCCESSFUL COLLECTION OF THE CORE SAMPLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992223 ↗
• MalfunctionDec 19, 2024Failure to Obtain Sample; Failure to Fire; Failure to Obtain Sample; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH HARD DENSITY TISSUE, THE FIRING BUTTON OF THE DEVICE ALLEGEDLY HAD A BIT STUCK BUT STILL WAS ABLE TO BE PRESSED. REPORTEDLY THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20973926 ↗
• InjurySep 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY BLEEDING AFTER PUNCTURE. IT WAS FURTHER REPORTED THAT THE BLEEDING WAS TREATED BY INJECTING ONE UNIT OF HEMOCOAGULASE OF RHIZOID VIPER INTRAMUSCULARLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20166311 ↗
• MalfunctionJul 18, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED LYMPH BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE, THE STYLET PART OF THE NEEDLE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THERE WAS AN ALLEGED DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779996 ↗
• MalfunctionMay 14, 2024Failure to Prime; Failure to Fire; Failure to Prime; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE, THE DEVICE ALLEGEDLY WAS FAILED TO PRIME. IT WAS FURTHER REPORTED THAT FAILED TO FIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309793 ↗
• MalfunctionFeb 12, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED LYMPH BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. REPORTEDLY, NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683199 ↗
• MalfunctionDec 28, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED RENAL BIOPSY THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE NEEDLE ALLEGEDLY FAILED TO FIRE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413136 ↗
• MalfunctionDec 21, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374192 ↗
• MalfunctionMar 2, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED LYMPH BIOPSY PROCEDURE, THE TIP OF NEEDLE WAS ALLEGEDLY BROKEN. A COAXIAL NEEDLE WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13647220 ↗
• MalfunctionJan 7, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH SOFT TISSUE, THE DEVICE ALLEGEDLY FAILED TO FIRE. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192268 ↗
• MalfunctionJul 9, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LIVER BIOPSY THROUGH NORMAL DENSITY TISSUE, THE CANNULA OF THE DEVICE ALLEGEDLY FAILED TO FIRE. A COAXIAL NEEDLE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142028 ↗
• MalfunctionMay 12, 2021Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LIVER BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812082 ↗
• MalfunctionMay 12, 2021Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LIVER BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812078 ↗
• MalfunctionMay 12, 2021Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LIVER BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. A COAXIAL NEEDLE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811793 ↗