The U.S. Food and Drug Administration (FDA) has expanded a recall of reprocessed electrophysiology and ultrasound catheters manufactured by Medline Industries. The agency determined that certain units may contain residual particulates following reprocessing, posing potential risks to patient safety.
The contamination could lead to serious adverse events including infection, embolism, or thrombosis in patients receiving catheter-based procedures. Healthcare facilities that have received affected catheters are urged to immediately cease use and verify their inventory against FDA guidance to identify potentially impacted devices.
The FDA is coordinating with Medline Industries and healthcare providers to ensure swift removal of affected catheters from clinical use. Patients who have received these devices should consult their healthcare provider regarding potential symptoms or complications. This is a developing story.
Source: Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound…
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