FDA Device recall Z-1487-2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
- FDA Device
- Class I
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class I recall of ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC by Cordis Us, citing 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, unpl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1487-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-03-24 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cordis Us |
| Distribution | n/a |
Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
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.
Identifiers
| code_info | UDI/DI 20705032056943; Lot Numbers: 35265335, 35264202 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1487-2023%22
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