Device 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.
Z-1174-2016
Product summary
- Event
- Event 73183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,985 units
- Official record key
device-enforcement:Z-1174-2016
Official wording
Reason: Incorrect cannula of the sheath introducer (smaller than intended).
Code information: Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Incorrect cannula of the sheath introducer (smaller than intended).