MAX-CORE MC1816Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 18g x 16cm · Class 2
Quick summary
This Bard MAX-CORE disposable core biopsy instrument is used to take tissue samples. Most of the 862 reports describe the instrument failing to fire, firing on its own or not collecting a sample, and some describe kidney biopsies that had to be finished with another device. The reports include 58 injuries and 1 death. 1 recall names this device; it began in October 2019 over complaints that the instrument failed to fire or collect samples, and the recall 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
- 848
- Deaths reported
- 1
- Injuries reported
- 57
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 848 adverse event reports that list this exact device (DI 00801741084478), received between May 2, 2017 and Sep 28, 2026 — classified as 1 death, 57 injuries, 790 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (600 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 Fire600
- Self-Activation or Keying136
- Failure to Obtain Sample107
- Failure to Prime56
- Adverse Event Without Identified Device or Use Problem43
- Difficult to Remove25
- Nonstandard Device25
- Material Twisted/Bent17
Patient problems
- No Clinical Signs, Symptoms or Conditions570
- No Consequences Or Impact To Patient150
- No Patient Involvement60
- Hemorrhage/Blood Loss/Bleeding35
- No Known Impact Or Consequence To Patient20
- Pneumothorax13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Hemoptysis6
Recent adverse event reports
The 25 most recent of 848 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Fire
A patient underwent an ultrasound guided kidney biopsy procedure through normal density tissue using a Maxcore device. During the procedure, it was reported that the outer cannula of the device not released from prime 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 50910753 ↗MalfunctionSep 11, 2026Failure to Obtain Sample; Failure to Fire
On (b)(6) 2026, a patient underwent a ultrasound guided kidney biopsy procedure through normal density tissue using Maxcore instrument. During the procedure the firing button got bit stuck but still pressed. 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 50734683 ↗MalfunctionSep 11, 2026Failure to Obtain Sample; Failure to Fire
On (b)(6) 2026, a patient underwent a ultrasound guided kidney biopsy procedure through normal density tissue using Maxcore instrument. During the procedure the firing button got bit stuck but still pressed. 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 50734680 ↗MalfunctionSep 9, 2026Failure to Fire
On (b)(6) 2026, a pediatric patient underwent a kidney biopsy procedure using a Maxcore device. During the procedure, it was reported that the cannula failed to retract. As a result, repeat puncture was performed. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689915 ↗MalfunctionSep 9, 2026Failure to Fire
On (b)(6) 2026, a patient underwent a kidney biopsy procedure using the Maxcore instrument. During the procedure, after the needle was inserted into the patient's body, the cannula failed to retract, resulting in the inability to obtain a tissue specimen. The same issue occurred upon retesting the cannula. As a precautionary measure, hemostatic agents were administered to the patient to prevent and manage bleeding. As the patient underwent multiple needle insertions, this may have increased the risk of renal hemorrhage. The patient's urine color, vital signs, and hemoglobin levels will be closely monitored. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50687610 ↗MalfunctionSep 9, 2026Failure to Fire
On (b)(6) 2026, a pediatric patient underwent a kidney biopsy procedure using the Maxcore instrument. After sampling, the cannula failed to retract. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50687609 ↗MalfunctionSep 1, 2026Difficult to Remove; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539152 ↗MalfunctionSep 1, 2026Difficult to Remove; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539149 ↗MalfunctionSep 1, 2026Difficult to Remove; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50538135 ↗MalfunctionAug 20, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342524 ↗MalfunctionAug 20, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342522 ↗MalfunctionAug 20, 2026Failure to Fire
On (b)(6), 2026, a patient underwent an ultrasound guided kidney biopsy procedure through tissue of normal density using a Maxcore instrument. During the procedure, the device cannula failed to fire, and the firing button became stuck, although it could still be pressed. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.This is report 4 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342521 ↗MalfunctionAug 20, 2026Failure to Fire
On (b)(6) 2026, a patient underwent an ultrasound guided kidney biopsy procedure through tissue of normal density using a Maxcore instrument. During the procedure, the device outer cannula failed to fire, and the firing bottom button became stuck, although it could still be pressed. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.This is report 6 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342519 ↗MalfunctionAug 20, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342518 ↗MalfunctionAug 20, 2026Failure to Fire
On (b)(6), 2026, a patient underwent an ultrasound guided kidney biopsy procedure through tissue of normal density using a Maxcore instrument. During the procedure, the device cannula failed to fire, and the firing button became stuck, although it could still be pressed. No coaxial needle was used. The procedure was completed using another device. There was no reported patient injury.This is report 3 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50342517 ↗MalfunctionAug 20, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50339419 ↗MalfunctionJul 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067238 ↗MalfunctionJul 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065516 ↗MalfunctionJul 27, 2026Failure to Fire
On (b)(6) 2026, a patient underwent a ultrasound guided kidney biopsy procedure through normal density tissue using Maxcore instrument. During the procedure, the instrument could not obtain the sample and firing button got stuck but still can be pressed. 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 50021036 ↗MalfunctionJul 21, 2026Failure to Fire; Material Twisted/Bent
ON (b)(4) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY USING THE MAXCORE DEVICE. DURING THE PROCEDURE, 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 25887245 ↗MalfunctionJun 5, 2026Device Markings/Labelling Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAXCORE INSTRUMENT. PRIOR TO THE PROCEDURE, THE DEVICE LABEL WAS ALLEGEDLY FOUND TO BE MISSING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25405251 ↗MalfunctionMay 22, 2026Failure to Fire
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED RENAL BIOPSY PROCEDURE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INTRODUCER NEEDLE COULDN'T BE FIRED. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25252411 ↗MalfunctionMay 20, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSTRUMENT OUTER CANNULA ALLEGEDLY COULD NOT BE FIRED. 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 25226128 ↗MalfunctionMay 20, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MAXCORE DEVICE. DURING THE PROCEDURE, THE OUTER CANNULA OF THE DEVICE CAN'T BE FIRED. 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 25226125 ↗MalfunctionMay 20, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT A ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSTRUMENT OUTER CANNULA ALLEGEDLY COULD NOT BE FIRED. 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 25226124 ↗
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 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.