Medline Industries recalled reprocessed St. Jude electrophysiology catheters on December 22, 2025. The recall affects 48 units potentially contaminated with residual materials. The defective catheters pose a high risk of inflammation and systemic infection.
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 includes various models of St. Jude Medical Supreme Diagnostic Electrophysiology Catheters. Models affected include 401211RH, 401222RH, 401223RH, among others. These were distributed nationwide in the U.S.
The recalled catheters may contain small particles of residual material. This contamination can lead to inflammatory responses, systemic infections, and serious complications such as cerebrovascular or pulmonary embolism.
Healthcare providers and patients should stop using these catheters immediately. Contact Medline Industries for further instructions and follow the recall guidelines provided.
For more information, contact Medline Industries at 1-800-633-5463 or visit their website. Detailed recall instructions are available at the FDA link.
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