Medline Industries recalled 7,913 reprocessed electrophysiology catheters on July 31, 2025. Residual particulates on patient-contacting surfaces pose a risk of serious infection and thrombus formation. Patients and healthcare providers must stop using these devices immediately.
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 specific lots of reprocessed Livewire Steerable Electrophysiology Catheters. Item numbers affected include 401575RH, 401582RH, and numerous others. The devices were distributed nationwide in the United States.
Certain lots of these catheters may contain small residual particulates. If these particles dislodge during use, they can cause severe inflammatory responses or systemic infections.
Patients and healthcare providers should stop using these catheters immediately. Contact Medline Industries for further instructions and possible refunds.
For more information, call Medline Industries at 1-800-633-5463 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2610-2025.
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