Medline Industries has expanded a previous recall of certain reprocessed electrophysiology and ultrasound catheters due to the potential presence of small residual particulates that could lead to infection, embolism, or thrombosis.
The latest list of affected devices, which are used in diagnostic cardiac procedures and ultrasound imaging, include those from Abbott, Biosense Webster, Siemens (ACUSON) and rebranded St. Jude Medical devices under Medline’s ReNewal line, according to a March 5 FDA notice. A full list of affected products was shared with healthcare providers and is accessible in the online alert.
If used, the devices may pose a risk of inflammatory response, systemic infection or embolism, according to the agency. While no serious injuries or deaths have been reported, the agency classified the recall as Class I, its most serious type.
Healthcare facilities were instructed to quarantine and destroy the affected products after submitting response forms to Medline. The company issued the original recall notice Dec. 22 and has since advised customers and distributors to alert downstream users.
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