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Recall Observatory FDA recall evidence

Device product

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC

Z-1483-2023

March 24, 2023

Class I

Product summary

Firm
Cordis US Corp
Event
Event 91922
Status
Ongoing
Classification
Class I
Quantity
283 units
Official record key
device-enforcement:Z-1483-2023

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 20705032053508; Lot Numbers: 35262517, 35263334, 35264204, 35264222, 35265345.

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.