Bard MAX-CORE Biopsy Instruments: Failure to Prime or Fire Risk
Bard recalls MAX-CORE Disposable Core Biopsy Instruments with specific model codes due to increased complaints of failure to prime, fire, obtain samples, or self-activation.
Use caution until it’s fixed
During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
Contact the company
What happened, in plain English
Bard is recalling certain MAX-CORE Disposable Core Biopsy Instruments because they have been reported to fail to prime, fire, obtain samples, or activate unexpectedly. This could lead to incomplete procedures or unintended device activation during medical use. Read more at govinfonow.com/recall/72963-bard-max-core-biopsy-instruments-failure-to-prime-or-fire.
Source Summary by GovInfoNow · govinfonow.com/recall/72963-bard-max-core-biopsy-instruments-failure-to-prime-or-fire · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0044-2018
Cite this page
“Bard MAX-CORE Biopsy Instruments: Failure to Prime or Fire Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72963-bard-max-core-biopsy-instruments-failure-to-prime-or-fire. Based on FDA recall #Z-0044-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2018%22&limit=1).
Why it’s dangerous
The instruments have been reported to fail to prime (prepare for use), fail to fire (release the sample), fail to obtain a sample, or activate unexpectedly. This could result in incomplete biopsies or unintended device activation during medical procedures.
Who’s affected
Medical professionals using the recalled MAX-CORE biopsy instruments for soft tissue biopsies are most at risk. Patients undergoing procedures with these instruments may face incomplete sampling or unexpected activation.
How to tell if you have this one
Check for product codes MC1410 (14g x 10cm), MC1616 (16g x 16cm), MC1816 (18g x 16cm), MC1820 (18g x 20cm), or MC1825 (18g x 25cm). The recall includes specific lot numbers listed in the official notice.
- Brand
Bard- Category
Medical device
What to do — step by step
Check Product Codes
Identify if your instrument has one of the product codes: MC1410, MC1616, MC1816, MC1820, or MC1825.
How this recall unfolded
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there specific lot numbers affected?
Yes, the recall includes specific lot numbers such as REBP0019, REBN0342, and others listed in the official notice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0044-2018 (September 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0044-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.