Quarantine Some Medline ReNewal Catheters

FDA says it is aware that Medline ReNewal has told affected customers that certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters should be removed from where they are sold or used. An agency Early Alert says Medline ReNewal stated that 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 particulates 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 pulmonary embolism or deep vein thrombosis,” FDA says.

As of 7/29, the notice says, Medline ReNewal had reported no serious injuries or deaths associated with the issue.