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Recall Observatory FDA recall evidence

Device product

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE

Z-1491-2023

March 24, 2023

Class I

Product summary

Firm
Cordis US Corp
Event
Event 91922
Status
Ongoing
Classification
Class I
Quantity
1087 units
Official record key
device-enforcement:Z-1491-2023

Official wording

Reason: 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.

Code information: UDI/DI 20705032054772; Lot Numbers: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.