Reported Oct 8, 2025 · Ongoing
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic…
Medline Industries, LP
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers
81102RH81104RH81107RH81174RH81402RH81404RH81405RH81472RH81473RH81474RH81531RH81532RH
- Lot codes and dates
Item Number/UDI-DI 81102RH 1019734413323981104RH 1019734413324681107RH 1019734413326081174RH 1019734413329181402RH 1019734413335281404RH 1019734413337681405RH 1019734413338381472RH 1019734413341381473RH 1019734413342081474RH 1019734413343781531RH 1019734413351281532RH 10197344133529LOTS EP250212 EP250214
- Amount recalled
- 7913 eaches
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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