Reported Oct 8, 2025 · Ongoing
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart.…
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 ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
- Lot codes and dates
- Item Number/UDI-DI D087031RH 10197344019557 LOTS
EP240731EP240814EP240826EP240903EP240916EP241003EP241014EP241028EP241104EP241112EP241202EP241209AEP241219EP241224EP250114EP250116EP250204EP250219
- Item Number/UDI-DI D087031RH 10197344019557 LOTS
- 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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