​Merit—HeartSpan Transseptal Needles: Labeled Needle Tip Curvature May Not Match Actual Needle Tip Curvature

February 10, 2021 | Strategic Insights for Health System


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In a January 27, 2021, Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Merit states that the labeled needle tip curvature of the above devices may not match the actual needle tip curvature. Merit also states that the needles themselves have been manufactured according to their design specifications. The discrepancy is likely to be noticed by the clinician because the incorrect curvature of the needle is obvious and would not be used, resulting in user dissatisfaction. In the unlikely event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which will likely require medical intervention. Merit further states that it has received no reports of patient harm or injury...

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