FDA Device recall Z-1489-2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
- 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 501814REC 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-1489-2023 |
| 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 501814REC
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 20705032054789; Lot Numbers: 35264223 |
|---|
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-1489-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.