MAX-CORERecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8,845
- Deaths reported
- 1
- Injuries reported
- 128
- Recalls
- 1
We found 11 models of MAX-CORE by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 8,845 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2016 and Sep 30, 2026 — classified as 1 death, 128 injuries, 8,716 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (6,428 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAX-CORE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 10 of these models · Recall details · FDA record ↗
Most reported MAX-CORE problems
Device problems
- Failure to Fire6,428
- Self-Activation or Keying1,519
- Failure to Obtain Sample1,022
- Failure to Prime637
- Nonstandard Device328
- Difficult to Remove162
- Material Twisted/Bent126
- Adverse Event Without Identified Device or Use Problem75
Patient problems
- No Clinical Signs, Symptoms or Conditions4,240
- No Consequences Or Impact To Patient3,592
- No Patient Involvement692
- No Known Impact Or Consequence To Patient226
- Hemorrhage/Blood Loss/Bleeding73
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available25
- Pain21
- Pneumothorax17
MAX-CORE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAX-CORE MC1616INSTRUMENT, BIOPSY1 recall4,258 reports
- MAX-CORE MC1820INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610INSTRUMENT, BIOPSY1 recall394 reports
- MAX-CORE MC1825INSTRUMENT, BIOPSY1 recall284 reports
- MAX-CORE MC1810INSTRUMENT, BIOPSY1 recall176 reports
- MAX-CORE MC1416INSTRUMENT, BIOPSY1 recall70 reports
- MAX-CORE MC2016INSTRUMENT, BIOPSY1 recall8 reports
- MAX-CORE MC2020INSTRUMENT, BIOPSY1 recall2 reports
- MAX-CORE MC2010INSTRUMENT, BIOPSY2 reports
Recent MAX-CORE adverse event reports
The 15 most recent reports across all models, 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 30, 2026Failure to Fire; Activation Problem
BARD MAX-CORE Disposable Core Biopsy Instrument did not fire currently when trigger was pressed, only 1/2 mechanisms activated.LOT: RELQ4188.REF: MC1825.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944753 ↗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 ↗
Other Bard Peripheral Vascular, Inc. products
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
- Dorado49 models · 387 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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