The U.S. Food and Drug Administration has classified a recall by Merit Medical Systems Inc. (NASDAQ:MMSI) as its most serious type, warning that continued use of certain dialysis catheter components could lead to severe injury or death.

Role Of The Device In Procedures

The 16F Dual-Valved Splittable Sheath Introducer is used to facilitate catheter placement into the vascular system and is included within the sterile packaging of finished dialysis products.

The FDA continues to monitor the situation, emphasizing the potential risks associated with continued use of the defective component.

FDA Flags High-Risk Recall

The agency said it is aware that Merit Medical has notified customers to remove specific 16F Dual-Valved Splittable Sheath Introducers from use and distribution.

These components are included in several dialysis-related kits, such as Centros and CentrosFLO Hemodialysis Catheters, ProGuide Chronic Dialysis Catheters, DuraMax Chronic Hemodialysis Catheters, and BioFlo DuraMax Catheters.

The recall involves pulling affected devices from circulation due to safety concerns tied to their performance.

According to the FDA, the recall stems from a design flaw that may prevent the sheath introducer from splitting as intended during procedures.

This malfunction could result in complications, including hemorrhage, embolization or thrombosis, procedure delays, and impaired catheter function. In some cases, it may also limit future vascular access options for patients.

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

Guidance Issued To Healthcare Providers

In a communication dated February 5, Merit Medical advised customers to immediately stop using the affected introducers.

The company also instructed users to apply recall notification stickers to impacted kits and destroy the introducer at the point of use.

Other components packaged within the same kits can continue to be used, the company noted.

MMSI Stock Price Activity: Merit Medical shares closed at $70.54 on Tuesday, according to Benzinga Pro data.

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