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 (ea)/UDI(case): 401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600RH 10888277407541 20888277407548; 401603RH 10888277407558 20888277407555; 401606RH 10888277407565 20888277407562; 401652RH 10888277407572 20888277407579; 401653RH 10888277407589 20888277407586; 401654RH 10888277407596 20888277407593; 401904RH 10888277407602 20888277407609; 401905RH 10888277407619 20888277407616; 401908RH 10197344020966 20197344020963; 401914RH 10888277407527 20888177407524; 401915RH 10888277407626 20888277407623; 401918RH 10888277407640 20888277407647; 401932RH 10888277407671 20888277407678; 401933RH 10888277407688 20888277407685; 401934RH 10888277407695 20888277407692; 401938RH 10888277407701 20888277407708; 401939RH 10888277407718 20888277407715; 401940RH 10888277407480 20888277407487; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753; LOTS EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 EP240212 EP240227 EP240311 EP240322 EP240411 EP240415 EP240422 EP240429 EP240507 EP240514 EP240520 EP240528 EP240607 EP240611 EP240710 EP240715 EP240723 EP240805 EP240812 EP240820 EP240829 EP240911 EP240923 EP240930 EP241008 EP241030 EP241125 EP250108
10888277407497, 20888277407494, 10888277407510, 20888277407517, 10888277407541, 20888277407548, 10888277407558, 20888277407555, 10888277407565, 20888277407562, 10888277407572, 20888277407579, 10888277407589, 20888277407586, 10888277407596, 20888277407593, 10888277407602, 20888277407609, 10888277407619, 20888277407616, 10197344020966, 20197344020963, 10888277407527, 20888177407524, 10888277407626, 20888277407623, 10888277407640, 20888277407647, 10888277407671, 20888277407678, 10888277407688, 20888277407685, 10888277407695, 20888277407692, 10888277407701, 20888277407708, 10888277407718, 20888277407715, 10888277407480, 20888277407487
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.