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 inse
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling HeartSpan Transseptal Needles (Catalog No. FND-019-01, Lot No. E1913644) because the labeled needle tip curvature of these needles may not match the actual needle tip curvature. These needles are used in medical procedures and consist of an outer needle cannula and an inner stylet. If an incorrect needle is unknowingly used due to this mislabeling, an unintended puncture of anatomy may occur that would likely require medical intervention.
The recalled lot consists of 587 units that were distributed 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, as well as to locations outside the United States. The record does not specify what action affected consumers should take.
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: 587 Units Lot/code info: Catalog Number FND-019-01, Lot Number E1913644; UDI: (01)00884450489345
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.