Reported Oct 8, 2025 · Ongoing
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH…
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 Livewire Steerable Electrophysiology Catheter Item Numbers
401575RH401582RH401600RH401603RH401606RH401652RH401653RH401654RH401904RH401905RH401908RH401914RH401915RH401918RH401932RH401933RH401934RH401938RH401939RH401940RH401941RH401991RH
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published 401575RH1088827740749720888277407494 401582RH1088827740751020888277407517 401600RH1088827740754120888277407548 401603RH1088827740755820888277407555 401606RH1088827740756520888277407562 401652RH1088827740757220888277407579 401653RH1088827740758920888277407586 401654RH1088827740759620888277407593 401904RH1088827740760220888277407609 401905RH1088827740761920888277407616 401908RH1019734402096620197344020963 401914RH1088827740752720888177407524 401915RH1088827740762620888277407623 401918RH1088827740764020888277407647 401932RH1088827740767120888277407678 401933RH1088827740768820888277407685 401934RH1088827740769520888277407692 401938RH1088827740770120888277407708 401939RH1088827740771820888277407715 401940RH1088827740748020888277407487 - 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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