Skip to content
Recall Observatory FDA recall evidence

Device product

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC

Z-1485-2023

March 24, 2023

Class I

Product summary

Firm
Cordis US Corp
Event
Event 91922
Status
Ongoing
Classification
Class I
Quantity
471 units
Official record key
device-enforcement:Z-1485-2023

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 20705032056745; Lot Numbers: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659

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.