Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartSpan Transseptal Needles Catalog No. FND-019-01 Recalled by Merit Medical Systems, Inc. Due to The labeled needle tip curvature of specific lots...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.
Affected Products
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
Quantity: 587 Units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 18 states: AL, CA, CT, GA, KY, LA, MD, MI, MT, NE, NJ, NY, PA, TX, UT, VA, WA, DC
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report