FDA-Device2025-10-08Class I
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH
Medline Industries, LP
Hazard
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.
Sold states
Domestic US distribution nationwide. International distribution pending. No international distribution.
Affected count
7913 eaches
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2610-2025Don't want to check this manually?
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