FDA-Device2025-10-08Class I
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
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 Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2612-2025Don't want to check this manually?
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