Medline Industries recalled 7,913 reprocessed AcuNav Ultrasound Catheters on July 31, 2025. The devices may contain harmful residual particulates that pose an infection risk. Patients and healthcare providers should stop using these devices immediately and follow recall instructions.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The recalled product includes Medline Item Numbers 10135910RH and 10135936RH. These ultrasound catheters were distributed domestically across the U.S. and are not for international distribution.
Some catheters may contain small residual particulates on patient-contacting surfaces. If these particulates dislodge during use, they can lead to serious health issues, including infections and thrombus formation.
No specific injury or incident counts were reported. However, the potential risks include systemic infections or thrombus formation leading to embolism.
Stop using the ultrasound catheters immediately. Contact Medline Industries or your healthcare provider for further instructions and follow the recall procedures.
Reach Medline Industries at their customer support for assistance. The recall details can also be found on the FDA's website.
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