Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 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 ins
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645. The recalled needles consist of an outer needle cannula and an inner stylet. The problem is that the labeled needle tip curvature on these specific needles may not match the actual needle tip curvature. If a healthcare provider unknowingly uses a needle with incorrect curvature, it could result in an unintended puncture of anatomy that would likely require medical intervention.
The recall involves 448 units distributed across the United States to consignees in Virginia, Nebraska, Washington DC, Michigan, New York, Kentucky, California, Texas, Maryland, Alabama, Georgia, Utah, Louisiana, Connecticut, Pennsylvania, Washington, Montana, and New Jersey. The needles were also distributed outside the United States. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: U.S. Consignees: VA, NE, Washington DC, MI, NY, KY, CA, TX, MD, AL, GA, UT, LA, CA, CT, PA, WA, MT and NJ. No government consignees. Also distributed OUS. Quantity: 448 Units Lot/code info: Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.