Z-1174-2016Class II

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and...

Name: Z-1174-2016 CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and...
Creator: Cordis Corporation
Published: 2015-12-31
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2015-12-31 / Terminated

FDA source

Cordis Corporation began a recall of CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer... on 2015-12-31. FDA classified it as Class II and gives the reason as "Incorrect cannula of the sheath introducer (smaller than intended)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1174-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-31
Posted: 2016-03-15
Terminated: 2016-08-25
Recalling firm: Cordis US Corp.
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.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Incorrect cannula of the sheath introducer (smaller than intended).
FDA root cause: Mixed-up of materials/components
Action: The firm, Cordis, sent an 'Urgent MEDICAL DEVICE CORRECTION (Field Safety Notice) dated 12/31/2015 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Read the Description of the problem section carefully to fully understand the issue involved. 2) Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product. 3) Keep a copy of this notice with any affected product. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis by fax to (908) 429-8287 Alternate fax (904) 928-5077. number or scan and email to [email protected]. 5) Share this letter with anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. 6) Maintain awareness of this notice until all affected product has been consumed. If vessel dilator to sheath incompatibility is experienced, you can report the incident through the standard complaint process (1-800-327-7714 Option 3). For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730."
Quantity in commerce: 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.
Product codes and lots: Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1174-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1174-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-14

Product code DRE

K970392Class IICordis Avanti+catheter Sheath Introducer SystemCordis Corp. / cleared 1997-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)