Specific lots of reprocessed electrophysiology and ultrasound 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.
Reason for recall: Specific lots of reprocessed electrophysiology and ultrasound 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. Distribution: Domestic US distribution nationwide. International distribution pending. No international distribution. Quantity: 7913 eaches Lot/code info: Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500; 10135936RH (For use on Siemens Systems) 10197344026517; LOTS EP241021 EP241114 EP241226 EP250213 LOTS EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219
10197344026500, 10197344026517
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.