MAX-CORE MC1610Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 16g x 10cm · Class 2
Quick summary
This Bard MAX-CORE biopsy instrument is a disposable device used to take tissue samples. Its 401 adverse event reports most often describe the instrument failing to fire or firing on its own, and some describe a bent needle stylet that was hard to remove from the patient. Reports list 1 injury and no deaths. There is 1 closed recall, started in October 2019, over rising complaints of failure 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
- 394
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 394 adverse event reports that list this exact device (DI 00801741084447), received between Jul 6, 2017 and Jul 27, 2026 — classified as 1 injury, 393 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (229 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 Fire229
- Self-Activation or Keying134
- Failure to Prime49
- Failure to Obtain Sample35
- Difficult to Remove19
- Material Twisted/Bent19
- Device Contamination with Chemical or Other Material12
- Nonstandard Device9
Patient problems
- No Consequences Or Impact To Patient225
- No Clinical Signs, Symptoms or Conditions113
- No Patient Involvement48
- Hemorrhage/Blood Loss/Bleeding7
- No Known Impact Or Consequence To Patient6
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 394 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guided breast biopsy procedure through hard tissue density using the Maxcore instrument. During the procedure, the device needle was found to be bent. It was further the firing button got stuck a bit and the needle was difficult to remove from the patient. 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 50021372 ↗MalfunctionJul 27, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guided breast biopsy procedure through hard tissue density using the Maxcore instrument. During the procedure, the device needle was found to be bent. It was further the firing button got stuck a bit and the needle was difficult to remove from the patient. 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 50021352 ↗MalfunctionJul 27, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guided breast biopsy procedure through hard tissue density using the Maxcore instrument. During the procedure, the device needle was found to be bent. It was further the firing button got stuck a bit and the needle was difficult to remove from the patient. 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 50021351 ↗MalfunctionJul 16, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE STYLET PART OF THE NEEDLE WAS BENT AND WAS DIFFICULT TO REMOVE FROM PATIENT. FURTHER IT WAS REPORTED THAT THE FIRING BUTTON GOT BIT STUCK BUT STILL CAN BE PRESSED. 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 25837847 ↗MalfunctionJul 16, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH HARD TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE STYLET PART OF THE NEEDLE WAS BENT AND WAS DIFFICULT TO REMOVE FROM PATIENT. FURTHER IT WAS REPORTED THAT THE FIRING BUTTON GOT BIT STUCK BUT STILL CAN BE PRESSED. 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 25837846 ↗MalfunctionMar 26, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, WHEN TRIGGERED, ONLY THE INNER TROCAR DEPLOYED. 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 24699214 ↗MalfunctionMar 26, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, WHEN TRIGGERED, ONLY THE INNER TROCAR DEPLOYED. 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 24699213 ↗MalfunctionMar 26, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE STYLET NEEDLE WAS BENT. IT WAS FURTHER REPORTED THAT THE FIRING BUTTON WAS A BIT STUCK BUT STILL COULD BE PRESSED. REPORTEDLY, THERE WAS DIFFICULTY IN REMOVING THE NEEDLE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696870 ↗MalfunctionMar 26, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE STYLET NEEDLE WAS BENT. IT WAS FURTHER REPORTED THAT THE FIRING BUTTON WAS A BIT STUCK BUT STILL COULD BE PRESSED. REPORTEDLY, THERE WAS DIFFICULTY IN REMOVING THE NEEDLE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696868 ↗MalfunctionMar 26, 2026Difficult to Remove; Failure to Fire; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING A MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE STYLET NEEDLE WAS BENT. IT WAS FURTHER REPORTED THAT THE FIRING BUTTON WAS A BIT STUCK BUT STILL COULD BE PRESSED. REPORTEDLY, THERE WAS DIFFICULTY IN REMOVING THE NEEDLE FROM THE PATIENT. NO COAXIAL NEEDLE WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696866 ↗MalfunctionMar 6, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A RENAL BIOPSY PROCEDURE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE BUTTON/ACTUATOR TRIGGER WAS ALLEGEDLY STUCK, AND THE STYLET (INNER NEEDLE) FAILED TO RELEASE FROM THE PRIMED POSITION WHEN FIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24529560 ↗MalfunctionMar 5, 2026Self-Activation or Keying
A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY SELF-ACTIVATED. NO COAXIAL NEEDLE 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 24517256 ↗MalfunctionMar 5, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, 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 USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516297 ↗MalfunctionFeb 19, 2026Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE BY USING THE MAXCORE. IT WAS REPORTED THAT DURING THE PROCEDURE, 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 24387070 ↗MalfunctionFeb 16, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE NEEDLE WAS BENT AND DIFFICULT THE REMOVE THE NEEDLE FROM THE PATIENT. 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 24342340 ↗MalfunctionFeb 16, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE THE NEEDLE WAS BENT AND DIFFICULT THE REMOVE THE NEEDLE FROM THE PATIENT. 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 24342337 ↗MalfunctionFeb 16, 2026Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDE BREAST BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE MAXCORE. DURING THE PROCEDURE, THE STYLET OF THE DEVICE NEEDLE BENT. FURTHER IT WAS REPORTED THAT DIFFICULTY IN REMOVING THE DEVICE FROM PATIENT. 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 24341931 ↗MalfunctionJan 7, 2026Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED LYMPH BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. PRIOR TO THE PROCEDURE, THE DEVICE¿S GUN BODY WAS STAINED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CONTACT WITH PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987508 ↗MalfunctionDec 1, 2025Failure to Obtain Sample; Failure to Fire; Failure to Obtain Sample; Failure to Fire
A PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE MAXCORE. DURING THE PROCEDURE, THE DEVICE WAS STICKING AND MISFIRING LATELY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677916 ↗MalfunctionDec 1, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING MAXCORE DEVICE. PRIOR TO THE PROCEDURE THE DEVICE ALLEGEDLY AUTOMATIC EJECTION. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677656 ↗MalfunctionNov 20, 2025Failure to Fire; Failure to Fire
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE USING THE MAXCORE. DURING THE PROCEDURE, THE OUTER CANNULA OF THE DEVICE 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 23603724 ↗MalfunctionOct 15, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE. DURING THE PROCEDURE, THE DEVICE DISCHARGED AUTOMATICALLY WITHOUT RETRIEVING A SPECIMEN. FURTHER IT WAS REPORTED THAT SUBSEQUENT ATTEMPTS TO RETRY THE NEEDLE ALSO RESULTED IN AUTOMATIC EJECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298954 ↗MalfunctionSep 12, 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 DEVICE. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY AUTO-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 23035788 ↗MalfunctionSep 12, 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 DEVICE. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY AUTO-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 23035783 ↗MalfunctionSep 12, 2025Self-Activation or Keying; Self-Activation or Keying
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, USING THE MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY AUTO FIRED. 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 23035782 ↗
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 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
- 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.