Bard recalls MAX-CORE Disposable Core Biopsy Instruments with failure to fire and sample issues. These devices are used for soft tissue biopsies. Check product codes and serial numbers for affected units.
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.
Bard is recalling disposable core biopsy instruments that have been reported to fail to fire or not obtain samples. This could lead to incomplete biopsies during medical procedures.
The instruments have been reported to fail to fire or not obtain samples during use, which could result in incomplete biopsies. This may require additional procedures or affect diagnostic accuracy.
Medical professionals who use these biopsy instruments for soft tissue procedures like liver, kidney, or prostate biopsies. Patients undergoing these procedures may be at risk if the device fails during use.
Check the product code/lot number on the instrument. Affected models include MC1410 (114g x10cm), MC1416 (14g x16cm), MC1610 (16g x10cm), and others listed in the product codes and serial numbers provided in the recall notice.
Look for the product code/lot number on the instrument to determine if it is affected. Affected models include MC1410, MC1416, MC1610, and others listed in the recall notice.
The instruments have been reported to fail to fire or not obtain samples during use, which could result in incomplete biopsies.
Check the product code/lot number on the instrument. Affected models include MC1410 (114g x10cm), MC1416 (14g x16cm), MC1610 (16g x10cm), and others listed in the recall notice.
No, the recall does not require immediate discontinuation. Affected units should be checked for the product code/lot number to determine if they are affected.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-0724-2020 — Bard Bard Hello, I own a Bard that is covered by recall Z-0724-2020 from Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
