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Cordis US Corp recalls ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Recalled May 17, 2023 · FDA recall Z-1489-2023 · Cordis US
Hazard
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. · FDA Class I
Units
40 units
Sold at
Worldwide distribution.
Description
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.
Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Manufacturer(s)
Cordis US Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →