Medline Industries, LP recalled 650 ViewFlex Xtra ICE Catheters on December 22, 2025. The recall affects devices that may contain small particles of residual material. Using these catheters poses a risk of serious health complications such as systemic infection or embolism.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
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 involves the ViewFlex Xtra ICE Catheter, model D087031RH, UDI-DI 20197344019554. The affected lots include EP250324, EP250416, EP250512, EP250521, EP250609, EP250630, EP250710, and EP250724. These catheters were distributed nationwide in the U.S.
These lots may contain small particles that can cause an inflammatory response, systemic infection, or other severe reactions. Complications may include cerebral or pulmonary embolism and deep vein thrombosis.
No specific injuries or incidents have been reported at this time. The recall is classified as Class I due to the potential high risk of serious health effects.
Patients and healthcare providers should stop using these catheters immediately. Contact Medline Industries, LP for detailed instructions on returning the product.
For more information, call Medline at 1-800-396-1999 or visit their website at https://www.medline.com.
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