Z-2079-2021Class II

Avanti+ Catheter Sheath Introducer -

Name: Z-2079-2021 Avanti+ Catheter Sheath Introducer -
Creator: Cordis Corporation
Published: 2021-06-09
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2021-06-09 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular... on 2021-06-09. FDA classified it as Class II and gives the reason as "The product in the packaging is larger (both inner and outer diameter) than the labeling indicates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2079-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-09
Posted: 2021-07-15
Terminated: 2023-02-16
Recalling firm: Cordis US Corp.
Product: Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: A letter and Acknowledgement Form sent on June 8, 2021 to each account. Actions requested on your part: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to determine if you have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures that the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: [email protected] 4) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 5) Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through Friday from 9:00 AM to 5:00 PM EDT. For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00 AM to 8:00 PM EDT. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: [email protected] or call (786) 313-2087.
Quantity in commerce: 680 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Product codes and lots: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2079-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2079-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)