Cordis US Corp Recall 91922
Description: ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Cordis US Corp Recall 91922 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1489-2023 |
| Event ID | 91922 |
| Event Description | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 40 units |
| Recall 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. |
| Device Classification | 20230517 |
| Device Code Info | UDI/DI 20705032054789; Lot Numbers: 35264223 |
| Center Classification Date | 20230511 |
| Recall Initiation Date | 20230324 |
| Recalling Firm | Cordis US Corp |
| Initial Notification | Letter |
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