The U.S. Food and Drug Administration confirmed that Merit Medical Systems has issued a recall of its 16F Dual‑Valved Splittable Sheath Introducer, a component used in several of the company’s dialysis catheters. The recall was initiated by Merit on February 5, 2026, and the FDA’s public acknowledgment was released on April 14, 2026.
The recall is driven by a design defect that may cause the sheath introducer to fail to split as intended, creating a risk of serious injury or death. The affected product lines include the CentrosFLO Hemodialysis Catheters and the DuraMax Chronic Hemodialysis Catheter, with 35,591 units of the former and 21,591 units of the latter identified as impacted.
Merit reported that two patients suffered serious injuries related to the defect, but no deaths have been reported to date. The company has instructed customers to discontinue use of the recalled devices and to remove them from inventory.
The recall carries significant product‑liability implications and could reduce revenue from the affected catheter lines. It also adds to Merit’s regulatory burden, following a prior Class I recall of the Prelude Short Sheath Introducer in March 2017. The recall involves products that were part of Merit’s 2023 acquisition of a dialysis portfolio from AngioDynamics, underscoring the company’s strategy to expand its dialysis offerings while managing the risks of integrating legacy devices.
The FDA’s acknowledgment signals ongoing monitoring of Merit’s compliance with safety and usage guidelines, and the company’s response will be closely watched by investors and healthcare providers for its impact on market position and financial performance.
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