Class II — Cordis Corporation
| Recalling firm | Cordis US Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect cannula of the sheath introducer (smaller than intended). |
| 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. |
| Quantity | 1,985 units |
| Distribution | US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii. |
| Initiated | 2015-12-31 |
| Classified | 2016-03-14 |
| Terminated | 2016-08-25 |
| Recall number | Z-1174-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cordis Corporation (Z-1174-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73183/
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