Medline Industries recalled 7,913 reprocessed electrophysiology catheters on July 31, 2025. The recall affects specific lots that may contain harmful particulates. Using these catheters could lead to serious health risks including embolism or deep vein thrombosis.
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 recall includes reprocessed Webster CS Catheter 10 Electrodes with Medline Item Numbers BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, and BD710FJ282RRH. These devices were distributed nationwide in the U.S. No price information is available.
Certain lots of these catheters may have small residual particulates on patient-contacting surfaces. These particulates can cause an inflammatory response or systemic infection.
There are no reported incidents or injuries at this time. However, the potential risks include granulomatous reactions, thrombus formation, and serious conditions like cerebral or pulmonary embolism.
Stop using the recalled catheters immediately. Patients and healthcare providers should follow the manufacturer's recall instructions and contact Medline Industries for guidance.
For further assistance, contact Medline Industries, LP at the phone number listed on their website. More details are available at the FDA recall page.
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