Merit Medical Removes Dialysis Catheter Introducer in FDA Class I Recall

Merit Medical is removing a component used in certain dialysis catheter kits after identifying a defect that could interfere with how the device functions during placement.

The issue involves the 16F Dual-Valved Splittable Sheath Introducer, which is used to help deliver a catheter into the vascular system. The sheath is designed to split and be removed once the catheter is in place. However, the company found that in some cases, it may not split as intended.

The FDA has classified the action as a Class I recall, its most serious category, indicating that continued use could lead to serious harm. According to the agency, the issue may result in complications such as hemorrhage, foreign bodies, procedure delays, embolization or thrombosis, impaired catheter function and loss of vessel for future vascular access.

The affected introducer is packaged within several Merit dialysis catheter kits, including Centros and CentrosFLO hemodialysis catheters, ProGuide chronic dialysis catheters and the DuraMax and BioFlo DuraMax catheter systems.

Merit has advised customers to stop using the introducer immediately, label affected kits and destroy the component at the point of use, while allowing other products in the kits to remain in use.

As of February 23, the company has reported two serious injuries and no deaths linked to the issue.

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Hemodialysis relies on consistent vascular access to allow blood to flow to and from the dialysis machine. As noted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), catheters are one of several access options used in this setting, particularly when immediate access is required or other access types are not available.

The affected component is part of Merit’s broader renal therapies portfolio, which includes devices designed to support long-term vascular access for dialysis patients.

In interventional care updates for the company, Merit Medical plans to acquire View Point Medical. The move aims to boost its therapeutic oncology portfolio, adding technologies focused on image-guided tumor treatment.

Merit’s recall comes amid other FDA safety actions involving catheter devices in 2026, including notices tied to catheter fracture and component breakage. In January, the agency posted a recall for certain Bard PowerPICC intravascular catheters tied to a risk of catheter fracture. In April, it issued an early alert for certain Cook Medical sizing catheters because marker bands on the devices could crack or break. The notices point to the risk of device failure during use and the potential for patient harm.

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