FDA announces new recall of reprocessed EP catheters due to risk of contamination
Medline ReNewal, Medline’s medical device reprocessing program, has announced that certain electrophysiology catheters should be removed from the market and returned to the manufacturer due to a risk that they may contain “small residual particulates.” The FDA shared the warning, adding that this issue has not been linked to any serious injuries or deaths.
“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,” according to the FDA’s advisory.
This recall only covers specific lots of reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters. Customers selling these devices have been asked to “quarantine all affected product immediately.” If the devices have been resold or transferred to another distributor, Medline is asking customers to share this information with them.
Click here for additional details, including a full list of the affected catheters. These devices have many uses, including the mapping, stimulation and recording of a variety of arrhythmias.
The FDA is still reviewing this situation. This early alert is part of the agency’s efforts to keep the public informed about potentially high-risk device issues.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.