MAX-CORE MC1616Recalls & reported problems
Bard Peripheral Vascular, Inc. · MAX-CORE® Disposable Core Biopsy Instrument, 16g x 16cm · Class 2
Quick summary
This Bard MAX-CORE biopsy instrument has 4,209 adverse event reports, with 4,170 malfunctions, 38 injuries and no deaths. The reports mostly describe the device failing to fire and failing to collect a tissue sample. The 1 recall, now closed, began in October 2019 over a rise in firing failures and missed samples. Reports rose from 337 in the prior 12 months to 1,061 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
- 4,258
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,258 adverse event reports that list this exact device (DI 00801741084454), received between Jan 16, 2017 and Sep 30, 2026 — classified as 36 injuries, 4,222 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (3,724 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 Fire3,724
- Failure to Obtain Sample499
- Self-Activation or Keying172
- Nonstandard Device100
- Failure to Prime91
- Material Twisted/Bent37
- Difficult to Remove32
- Improper or Incorrect Procedure or Method12
Patient problems
- No Clinical Signs, Symptoms or Conditions2,596
- No Consequences Or Impact To Patient1,307
- No Patient Involvement261
- No Known Impact Or Consequence To Patient68
- Hemorrhage/Blood Loss/Bleeding17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Hematoma6
- Injury5
Recent adverse event reports
The 25 most recent of 4,258 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951845 ↗MalfunctionSep 30, 2026Failure to Fire
On (b)(6) 2026, a patient underwent a kidney biopsy procedure using the Maxcore instrument. During the procedure, a new biopsy needle was used; however, the same issue allegedly occurred, with the needle opening prior to exiting the patient's body, resulting in loss of the collected tissue sample. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947218 ↗MalfunctionSep 30, 2026Failure to Fire
On (b)(6) 2026, a patient underwent a kidney biopsy procedure using the Maxcore instrument. During the procedure, a new biopsy needle was used; however, the same issue allegedly occurred, with the needle opening prior to exiting the patient's body, resulting in loss of the collected tissue sample. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946969 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929323 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929315 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929313 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929312 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929311 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927855 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922213 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922210 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922207 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922205 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922203 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922202 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922197 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922195 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922193 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922192 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922190 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922186 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922174 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922171 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922170 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921345 ↗
Other INSTRUMENT, BIOPSY devices
- 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
- 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.