Merit Medical recalls CorVocet Biopsy Systems with misaligned components that may cause needle stick injuries during use. Affected models include CORA1410/B and others listed in the recall notice.
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
Merit Medical is recalling certain CorVocet Biopsy Systems due to misaligned components that could cause the needle to eject outside the body, potentially leading to needle stick injuries for users or patients. This recall affects specific model numbers and production lots.
The biopsy systems have components that are misaligned due to manufacturing assembly equipment issues. When triggered outside the body, the needle may eject unexpectedly, causing injury to the user or patient through needle stick incidents.
Users of the recalled CorVocet Biopsy Systems, particularly medical professionals performing biopsies, are at risk of needle stick injuries if the device malfunctions. Patients undergoing procedures with these systems may also be affected.
Check for the catalog codes listed in the recall notice: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, and other variants. Also verify the production lot numbers provided for specific distribution channels.
Identify the catalog code on your CorVocet Biopsy System to determine if it is affected by this recall.
Reach out to Merit Medical Systems for further guidance on the recall and potential remedies.
The affected models include CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, and other variants listed in the recall notice.
Check the catalog code on your device against the list provided in the recall notice, including specific production lot numbers for certain distributions.
Contact Merit Medical Systems directly for guidance on the recall and potential next steps.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0138-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0138-2023 from Merit Medical. 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.
