CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product… — Class II medical device recall Z-1174-2016
Terminated recall by Cordis Corporation, reported 2016-03-23, distributed nationwide. Incorrect cannula of the sheath introducer (smaller than intended).
| Recall number | Z-1174-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2015-12-31 |
| Classified | 2016-03-14 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2016-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,985 units |
| UPC / GTIN / UDI-DI | 20705032010389 |
| Lot numbers | 17305580 |
| Model numbers | 504656X |
| Expiration dates | 2018-07-31 |
Product
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
Reason for recall
Incorrect cannula of the sheath introducer (smaller than intended).
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-1174-2016. 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.