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 81102RH 10197344133239; 81104RH 10197344133246; 81107RH 10197344133260; 81174RH 10197344133291; 81402RH 10197344133352; 81404RH 10197344133376; 81405RH 10197344133383; 81472RH 10197344133413; 81473RH 10197344133420; 81474RH 10197344133437; 81531RH 10197344133512; 81532RH 10197344133529; LOTS EP250212 EP250214
10197344133239, 10197344133246, 10197344133260, 10197344133291, 10197344133352, 10197344133376, 10197344133383, 10197344133413, 10197344133420, 10197344133437, 10197344133512, 10197344133529
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.