MAX-CORE MC1410Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 14g x 10cm · Class 2
Quick summary
This Bard MAX-CORE biopsy instrument is a disposable device used to take tissue samples. Its 402 adverse event reports mostly describe the instrument firing on its own, failing to prime or fire, and sometimes getting stuck in the patient. Reports list 8 injuries and no deaths. There is 1 closed recall, started in October 2019, after complaints rose that the instrument failed to fire or collect samples.
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
- 399
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 399 adverse event reports that list this exact device (DI 00801741084423), received between Oct 7, 2016 and May 8, 2026 — classified as 8 injuries, 391 malfunctions.
The most frequently reported specific device problem is “Self-Activation or Keying” (305 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
- Self-Activation or Keying305
- Failure to Prime108
- Failure to Fire84
- Difficult to Remove45
- Failure to Obtain Sample38
- Material Twisted/Bent18
- Adverse Event Without Identified Device or Use Problem5
- Device Contamination with Chemical or Other Material4
Patient problems
- No Consequences Or Impact To Patient227
- No Clinical Signs, Symptoms or Conditions111
- No Patient Involvement57
- Pain10
- Hemorrhage/Blood Loss/Bleeding4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Needle Stick/Puncture1
- Rupture1
Recent adverse event reports
The 25 most recent of 399 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FIRED ON ITS OWN. 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 25120481 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FIRED ON ITS OWN. 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 25120306 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FIRED ON ITS OWN. 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 25120300 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FIRED ON ITS OWN. 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 25120298 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY MISFIRED ON ITS OWN. 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 25120188 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY MISFIRED ON ITS OWN. 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 25120185 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE THE DEVICE ALLEGEDLY FIRED ON ITS OWN. 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 25120184 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY MISFIRED ON ITS OWN. 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 25119967 ↗MalfunctionMay 8, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE VIA FATTY TISSUE DENSITY USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY MISFIRED ON ITS OWN. 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 25119966 ↗MalfunctionApr 6, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INSTRUMENT NEEDLE BENT AND THE NEEDLE BECAME DIFFICULT TO REMOVE FROM THE PATIENT. ADDITIONALLY, THE FIRING BUTTON BECAME STUCK. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS REPORTED NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788822 ↗MalfunctionApr 6, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INSTRUMENT NEEDLE BENT AND THE NEEDLE BECAME DIFFICULT TO REMOVE FROM THE PATIENT. ADDITIONALLY, THE FIRING BUTTON BECAME STUCK. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS REPORTED NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788817 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24780906 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24780876 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773281 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773279 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773278 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773277 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773276 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773275 ↗MalfunctionApr 3, 2026Difficult to Remove; Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INNER NEEDLE OF THE DEVICE FIRED AND THEN JAMMED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PAINFUL TO REMOVE DUE TO THE CUTTING CHAMBER BEING OPEN. 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; Pain
MAUDE report 24773147 ↗MalfunctionJan 28, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE BIOPSY NEEDLE WAS HIT, CAUSING IT TO OPEN INSIDE THE BREAST (CUTTING LIKE A KNIFE), AND THE PATIENT WAS HARMED WHILE TAKING THE SAMPLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197186 ↗MalfunctionDec 26, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD DENSITY TISSUE, USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE STYLET OF THE NEEDLE WAS ALLEGEDLY BENT AND HAD DIFFICULTY IN REMOVING THE PRODUCT FROM PATIENT. NO COAXIAL WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895383 ↗InjuryOct 27, 2025Failure to Fire; Material Twisted/Bent; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE NEEDLE WAS INSERTED INTO THE BREAST AND FIRED. HOWEVER, THE TISSUE ACQUISITION MECHANISM AT THE TIP OF THE NEEDLE (NEEDLE NOTCH) DID NOT FUNCTION PROPERLY. THE PATIENT REPORTED INJURY, INCLUDING SKIN DEFORMATION AND TRAUMA IN THE BREAST AREA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Skin Erosion
MAUDE report 23388374 ↗MalfunctionOct 23, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH DENSE TISSUE DENSITY USING A MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE HAD BEEN PREMATURELY ACTIVATED. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365394 ↗MalfunctionOct 23, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH DENSE TISSUE DENSITY USING A MAXCORE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE HAD BEEN PREMATURELY ACTIVATED. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365389 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.