Reported May 17, 2023 · Ongoing
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
Cordis US Corp.
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: Cordis US Corp · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
- Lot codes and dates
- UDI/DI 20705032056851
- Lot Numbers35265661
- Amount recalled
- 54 units
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Why it was recalled
Stop using this product now
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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