MAX-CORE MC1820Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 18g x 20cm · Class 2
Quick summary
This Bard MAX-CORE is a disposable core biopsy instrument used to take tissue samples. Its 2,409 reports mostly describe the device failing to fire, firing on its own, and failing to collect a sample, and mention 16 injuries and no deaths. One recall, started in October 2019 and now closed, followed complaints that the instrument failed to fire or obtain samples. Reports fell from 99 in the prior 12 months to 25 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,404
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,404 adverse event reports that list this exact device (DI 00801741084485), received between Dec 2, 2016 and Sep 28, 2026 — classified as 16 injuries, 2,388 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (1,542 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Failure to Fire1,542
- Self-Activation or Keying564
- Failure to Obtain Sample277
- Failure to Prime248
- Nonstandard Device193
- Device Contamination with Chemical or Other Material18
- Adverse Event Without Identified Device or Use Problem16
- Difficult to Remove15
Patient problems
- No Consequences Or Impact To Patient1,443
- No Clinical Signs, Symptoms or Conditions612
- No Patient Involvement212
- No Known Impact Or Consequence To Patient132
- Hemorrhage/Blood Loss/Bleeding7
- Pain5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Intermenstrual Bleeding2
Recent adverse event reports
The 25 most recent of 2,404 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Fire
On (b)(6) 2026, a patient underwent an ultrasound guided kidney biopsy procedure through normal density tissue using the Maxcore instrument. During the procedure, the device failed to fire, and the firing button became stuck, although it could still be pressed. No coaxial needle was 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 50913804 ↗MalfunctionSep 25, 2026Difficult to Remove; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guide liver biopsy procedure via soft density tissue using the Maxcore instrument. During the procedure, the device needle was allegedly bent and had difficulties to remove from patients body. 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 50894659 ↗MalfunctionSep 25, 2026Difficult to Remove; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guide liver biopsy procedure via soft density tissue using the Maxcore instrument. During the procedure, the device needle was allegedly bent and had difficulties to remove from patients body. 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 50894655 ↗MalfunctionSep 25, 2026Difficult to Remove; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guide liver biopsy procedure via soft density tissue using the Maxcore instrument. During the procedure, the device needle was allegedly bent and had difficulties to remove from patients body. 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 50894654 ↗MalfunctionSep 2, 2026Failure to Fire
On (b)(6) 2026, a patient underwent a kidney biopsy procedure using a Maxcore instrument. During the procedure, after two tissue samples were collected, the healthcare professional triggered the device to obtain a third sample. However, the outer sheath failed to deploy, and only the inner needle fired. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563750 ↗MalfunctionMay 6, 2026Self-Activation or Keying; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE OUTER CANNULA COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. FURTHER RE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092334 ↗MalfunctionApr 29, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH SOFT DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE CANNULA WAS NOT FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25030463 ↗MalfunctionApr 29, 2026Failure to Fire
ON (B)(6) 2026, A 32-YEAR-OLD FEMALE PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH SOFT DENSITY TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE INNER STYLET WAS FIRED, BUT THE OUTER CORING NEEDLE DID NOT FIRE, AND NO SAMPLE WAS OBTAINED. 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 25024405 ↗MalfunctionApr 23, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING MAXCORE DEVICE. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FAILED TO POP OUT, AS THE ACTUATOR BUTTON/TRIGGER FELT STUCK, AND UNABLE TO COLLECT A SAMPLE. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961805 ↗MalfunctionMar 26, 2026Failure to Fire
ON (B)(6) 2026 A PATIENT UNDERWENT THE KIDNEY BIOPSY USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE OUTER CANNULA FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697730 ↗MalfunctionMar 5, 2026Failure to Obtain Sample; Failure to Fire
A PATIENT UNDERWENT A SONO GUIDED KIDNEY BIOPSY PROCEDURE BY USING MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE GOT ALLEGEDLY STUCK WHILE FIRING THE DEVICE AND UNABLE TO CUT THE TISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516414 ↗MalfunctionMar 5, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE BY USING MAXCORE DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE INNER NEEDLE AND EJECTOR NEEDLE ALLEGEDLY FAILED TO EJECT SYNCHRONOUSLY, RESULTING IN AN INEFFECTIVE SECTION. 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 24515932 ↗MalfunctionMar 5, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE BY USING MAXCORE DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE INNER NEEDLE AND EJECTOR NEEDLE ALLEGEDLY FAILED TO EJECT SYNCHRONOUSLY, RESULTING IN AN INEFFECTIVE SECTION. 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 24515926 ↗InjuryMar 3, 2026Failure to Obtain Sample
ON (B)(6) 2026, A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN THE SAMPLE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A RENAL BIOPSY INJURY. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24493280 ↗MalfunctionFeb 27, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH HARD TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE NEEDLE WAS BENT. FURTHER IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL 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 24466405 ↗MalfunctionJan 30, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE OUTER CANNULA COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219233 ↗MalfunctionDec 18, 2025Failure to Fire; Failure to Fire
A PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE OUTER CANNULA IS NOT RELEASED FROM THE PRIME POSITION. NO COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835960 ↗MalfunctionDec 12, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MAXCORE DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL 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 23786665 ↗MalfunctionNov 3, 2025Failure to Prime; Failure to Fire; Failure to Prime; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. IT WAS FURTHER REPORTED THAT THERE WAS LITTLE HARD IN FULLY PRIMING THE DEVICE. NO COAXIAL 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 23449450 ↗MalfunctionNov 3, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE SPECIMEN WAS EJECTED FROM THE APERTURE AFTER FIRING. THE FIRST BUTTON UNEXPECTEDLY JUMPED BACK UP, RESULTING IN THE SPECIMEN DROPPING TO THE FLOOR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448345 ↗MalfunctionOct 22, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE BIOPSY GUN DIDN'T FIRE AFTER PRIMING. NO COAXIAL NEEDLE WAS USED AND THE PROCEDURE WAS COMPLETED WAS ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356548 ↗MalfunctionOct 6, 2025Failure to Obtain Sample; Failure to Fire; Failure to Obtain Sample; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCOR DEVICE. DURING THE PROCEDURE THE DEVICE FAILED TO OBTAIN SAMPLES. IT WAS FURTHER REPORTED THAT SOMETIMES ONLY FIRED. NO COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23220523 ↗InjurySep 29, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PROSTATE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE FIRED WITHOUT ANY INPUT. THE PATIENT'S URETHRA WAS PUNCTURED, AND THE DOCTOR HAD TO SEND THE PATIENT TO THE EMERGENCY DEPARTMENT IMMEDIATELY. THE PATIENT WAS TREATED USING THE STANDARD PROCEDURE. THE PATIENT HAS STABILIZED BUT WILL NEED SOME TIME TO RECOVER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding
MAUDE report 23164623 ↗MalfunctionSep 25, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY USING MAXCORE INSTRUMENT. PRIOR TO THE PROCEDURE THEY NOTICED HAIR IS INSIDE THE DEVICE AND DEVICE IS NOT OPENED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23143300 ↗MalfunctionSep 15, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MAXCORE. DURING THE PROCEDURE, THE OUTER CANNULA OF THE DEVICE 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 23048712 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
- MAX-CORE MC1825Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall284 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.