MAX-CORE MC1416Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 14g x 16cm · Class 2
Quick summary
This Bard MAX-CORE is a disposable core biopsy instrument used to take tissue samples, often with ultrasound guidance. The 70 reports mostly describe the needle failing to fire or firing on its own, plus some that would not prime, bent or broke, or were hard to remove from the patient. Reports mention 3 injuries, including one hematoma needing compression and observation, and no deaths. One recall began in October 2019 after the company saw a rise in failure-to-fire complaints; it is closed.
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
- 70
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00801741084430), received between Nov 21, 2016 and May 6, 2026 — classified as 3 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (40 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 Fire40
- Self-Activation or Keying23
- Failure to Prime9
- Break3
- Difficult to Remove2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient12
- No Patient Involvement9
- Hematoma4
- Pain1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE NEEDLE WAS BENT, AND NEEDLE WAS VERY DIFFICULT TO REMOVE FROM THE PATIENT BODY. 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 25092025 ↗MalfunctionDec 23, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE BY USING THE MAXCORE INSTRUMENT. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PUNCTURE NEEDLE WAS ALLEGEDLY FOUND TO BE BROKEN WHEN USED AND DID NOT REBOUND. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874520 ↗InjuryNov 19, 2025Failure to Fire; Failure to Fire
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE OUTER CANNULA COULD NOT BE FIRED. IT WAS FURTHER REPORTED THAT ONE PATIENT EXPERIENCED HEMATOMA FORMATION, WHICH REQUIRED 5 MINUTES OF COMPRESSION, HOSPITAL ADMISSION AND OBSERVATION FOR 4 HOURS, AND PAIN RELIEF MEDICATIONS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Hematoma
MAUDE report 23590906 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22011398 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22011221 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22011171 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6), 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010949 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010860 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A 78-YEAR-OLD FEMALE PATIENT WAS UNDERGOING AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010677 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010631 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010437 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010307 ↗MalfunctionMay 13, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A 78-YEAR-OLD FEMALE PATIENT WAS UNDERGOING AN ECHOGRAPHY GUIDED KIDNEY BIOPSY, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INNER STYLET OF THE DEVICE ALLEGEDLY FAILED TO FIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009866 ↗MalfunctionMay 12, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE, THE NEEDLE GROOVE AND NEEDLE TIP ARE BIFURCATED, PREVENTING TISSUE STRIPS FROM BEING PUNCTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22001294 ↗MalfunctionMay 12, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE, THE NEEDLE GROOVE AND NEEDLE TIP ARE BIFURCATED, PREVENTING TISSUE STRIPS FROM BEING PUNCTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22001290 ↗MalfunctionAug 12, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING A RENAL BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DIDN'T RETRACT PROPERLY. IT WAS FURTHER REPORTED THAT THE EXAMINATION TOOK A LITTLE LONGER THAN EXPECTED AND THE PATIENT HAD TO BE RE-SAMPLED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958741 ↗MalfunctionJun 3, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE CANNULA OF THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19446304 ↗MalfunctionJun 3, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE CANNULA OF THE DEVICE ALLEGEDLY FAILED TO FIRE. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19446095 ↗MalfunctionMay 22, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED RENAL BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE VIA THE TANGENTIAL OBLIQUE APPROACH, THE NEEDLE ALLEGEDLY DID NOT CLOSE TO TAKE THE SAMPLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A KIDNEY WOUND WITH AN INTRA AND PERI-RENAL HAEMATOMA WHICH REQUIRED HOSPITALIZATION FOR MANAGEMENT. REPORTEDLY, THE HEMATOMA WAS TREATED WITH ICE PRESSURE. A COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions
MAUDE report 19370116 ↗MalfunctionMay 22, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED RENAL BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE VIA THE TANGENTIAL OBLIQUE APPROACH, THE NEEDLE ALLEGEDLY DID NOT CLOSE TO TAKE THE SAMPLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A KIDNEY WOUND WITH AN INTRA AND PERI-RENAL HAEMATOMA WHICH REQUIRED HOSPITALISATION FOR MANAGEMENT. REPORTEDLY, THE HEMATOMA WAS TREATED WITH ICE PRESSURE. A COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions
MAUDE report 19369422 ↗MalfunctionApr 24, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY CAN¿T BE FIRED. 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 19169883 ↗MalfunctionApr 24, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY CAN¿T BE FIRED. 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 19169882 ↗MalfunctionApr 24, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY CAN¿T BE FIRED. 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 19169881 ↗MalfunctionApr 18, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE OUTER CANNULA OF THE DEVICE ALLEGEDLY CAN¿T BE FIRED. A COAXIAL WAS NOT 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 19133224 ↗MalfunctionApr 18, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A RENAL BIOPSY PROCEDURE, THE FIRST PUNCTURE WAS PERFORMED WITHOUT DIFFICULTY, HOWEVER DURING THE SECOND AND THIRD PUNCTURES, THE STYLET WAS TRIGGERED BUT NOT THE CANNULA, RESULTING IN FAILED BIOPSIES. IT WAS FURTHER REPORTED THAT FOURTH AND FIFTH PUNCTURES WERE THEN PERFORMED WITH THE SAME DEVICE WITHOUT INCIDENT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19132090 ↗
Other INSTRUMENT, BIOPSY devices
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- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.