Merit Medical recalls Heartspan Transseptal Needles (Catalog FND-019-02, Lot E1913645) due to possible incorrect needle tip curvature causing unintended anatomy punctures requiring medical intervention.
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Merit Medical is recalling specific Heartspan Transseptal Needles (Catalog FND-019-02, Lot E1913645) because the needle tip curvature might not match what's labeled. Using these needles incorrectly could cause unintended punctures that need medical treatment.
The needles' tip curvature might not match the labeled design. If the wrong curvature is used, it could accidentally puncture unintended anatomy, requiring medical intervention.
Healthcare professionals using these needles for procedures are most at risk. Patients receiving these needles during procedures may experience unintended punctures.
Check for Catalog Number FND-019-02 and Lot Number E1913645 on the needle packaging. The product includes an outer needle cannula and an inner stylet.
Verify the catalog number (FND-019-02) and lot number (E1913645) on the needle packaging.
The needle tip curvature may not match the labeled design, which could cause unintended anatomy punctures requiring medical intervention.
The recall record does not specify a remedy, so check with Merit Medical Systems for guidance.
Look for Catalog Number FND-019-02 and Lot Number E1913645 on the packaging.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2021 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1263-2021 from Merit Medical Systems. 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.
