Medline Industries recalled 7,913 reprocessed ViewFlex Xtra ICE catheters on July 31, 2025. The recall affects specific lots due to potential residual particulates that may cause serious health risks. Patients and healthcare providers must stop using the 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
The recall includes Medline Item Numbers D087031RH, specifically lots EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, and EP250219. The catheters were distributed nationwide in the United States.
The affected catheters may contain small residual particulates on patient-contacting surfaces. This poses a risk of inflammatory response or systemic infection, and dislodged particulates could lead to serious conditions such as cerebral or pulmonary embolism.
As of now, there are no reports of injuries or deaths associated with the recalled catheters. However, the potential for serious health complications exists.
Patients and healthcare providers should stop using the affected catheters immediately. They should follow the recall instructions provided by Medline Industries and contact their healthcare provider for further instructions.
For more information, contact Medline Industries, LP. Visit their website or call their customer service for assistance.
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