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Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
The FDA is aware that Medline ReNewal has issued a letter to affected customers recommending certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters be removed from where they are used or sold.
Specific lots of reprocessed electrophysiology 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.
As of July 29, Medline ReNewal has reported no serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline ReNewal at recalls@medline.com or 1-866-359-1704.
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