ANGIOGUARD RX / XP Emboli Capture Guidewire System — Class I medical device recall Z-1489-2023
Ongoing recall by Cordis US Corp, reported 2023-05-17. There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include
| Recall number | Z-1489-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis US Corp, Miami Lakes, FL, United States |
| Recall initiated | 2023-03-24 |
| Classified | 2023-05-11 |
| Reported by FDA | 2023-05-17 |
| Quantity | 40 units |
| UPC / GTIN / UDI-DI | 20705032054789 |
| Lot numbers | 35264223 |
| Model numbers | 501814REC |
Product
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1489-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.