Avanti¿+ Catheter Sheath Introducer — Class II medical device recall Z-2079-2021
Terminated recall by Cordis Corporation, reported 2021-07-21, distributed nationwide. The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
| Recall number | Z-2079-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2021-06-09 |
| Classified | 2021-07-15 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 680 units |
| Reason classes | labeling |
| Lot numbers | 17919780, 17988227 |
| Model numbers | 504-657A |
| Expiration dates | 2022-12-31, 2023-10-31 |
Product
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reason for recall
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
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-2079-2021. 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.