Medline Industries recalled 7,913 electrophysiology catheters on July 31, 2025, due to contamination concerns. Specific lots may contain small residual particulates, posing risks of systemic infection and thrombus formation. Patients and healthcare providers should 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 Medline Item Numbers 81102RH, 81104RH, 81107RH, 81174RH, 81402RH, 81404RH, 81405RH, 81472RH, 81473RH, 81474RH, 81531RH, and 81532RH. These devices were distributed nationwide in the United States.
The affected catheters may have residual particulates on patient-contacting surfaces. If these particulates dislodge during use, they can lead to serious health complications such as granulomatous reactions or thrombus formation, potentially causing embolism.
There have been no reported injuries or incidents directly associated with the use of these devices as of the recall date.
Patients and healthcare providers should stop using the affected catheters immediately. Contact Medline Industries, LP or your healthcare provider for further instructions.
For questions, call Medline Industries at 1-800-396-2020 or visit their website for details on the recall.
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