Merit Medical Systems recalls HeartSpan Transseptal Needles (Catalog FND-019-01, Lot E1913644) due to potential incorrect needle tip curvature causing unintended anatomy puncture 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 Systems is recalling specific HeartSpan Transseptal Needles (Catalog No. FND-019-01, Lot No. E1913644) because the needle tip curvature might not match what's labeled. Using these needles incorrectly could cause unintended punctures that need medical help.
The needles' tip curvature might not match the labeled design. If the wrong curvature is used, it could accidentally puncture anatomy, requiring medical intervention.
Patients using these needles for procedures like cardiac ablation may be affected. Medical professionals using the needles during procedures are most at risk.
Check for Catalog Number FND-019-01 and Lot Number E1913644 on the needle packaging. The product includes an outer needle cannula and inner stylet with flexible tubing.
Look for Catalog Number FND-019-01 and Lot Number E1913644 on the needle packaging.
The recalled needles are Catalog No. FND-019-01, Lot No. E1913644.
The needle tip curvature may not match the labeled design, which could cause unintended anatomy puncture requiring medical intervention.
The recall does not require immediate stop use; check the product details to see if you have the specific lot number.
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-1262-2021 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1262-2021 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.
