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Cordis US Corp Recall 91922

Description: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

Cordis US Corp Recall 91922 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1487-2023
Event ID91922
Event DescriptionANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Product TypeDevices
DistributionWorldwide distribution.
Quantity146 units
Recall ReasonThere 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.
Device Classification20230517
Device Code InfoUDI/DI 20705032056943; Lot Numbers: 35265335, 35264202
Center Classification Date20230511
Recall Initiation Date20230324
Recalling FirmCordis US Corp
Initial Notification Letter
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