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Recall Observatory FDA recall evidence

Device product

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE

Z-1493-2023

March 24, 2023

Class I

Product summary

Firm
Cordis US Corp
Event
Event 91922
Status
Ongoing
Classification
Class I
Quantity
385 units
Official record key
device-enforcement:Z-1493-2023

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 20705032056820; Lot Numbers: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660

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.