Z-1143-2013Class II

Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass...

Name: Z-1143-2013 Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass...
Creator: Elana, Inc.
Published: 2013-02-14
License: https://open.fda.gov/license/

Elana, Inc. / initiated 2013-02-14 / Terminated

FDA source

Elana, Inc. began a recall of Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique on 2013-02-14. FDA classified it as Class II and gives the reason as "Distribution of an unapproved device into interstate commerce". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1143-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-14
Posted: 2013-04-18
Terminated: 2013-05-09
Recalling firm: Elana, Inc.
Product: Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Distribution of an unapproved device into interstate commerce.
FDA root cause: No Marketing Application
Action: Elana Inc. issued an Urgent: Medical Device Recall letter on February 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the Elana Catheter Sizer 2.0 as soon as possible. The Sizer 2.0 was intended as an optional accessory to the Elana Surgical Kit. The Elana Surgical Kit may be used properly without the Elana Catheter Sizer 2.0. Please acknowledge receipt of these instructions immediately by Email: [email protected] or Fax: 301-215-7038. The return shipping address for the Sizer 2.0 is Elana, Inc., 10480 Little Patuxent Parkway, Suite 400, Columbia, MD 21044 USA. Contact information for questions: Phone: 301-215-7010 or 443-538-4923 or +1 31 30 2537276 www.elana.com.
Quantity in commerce: 3 devices
Distribution: Distributed in the states of Pennsylvania, Texas, and New York.
Product codes and lots: Model 280, S/N 776, S/N 706, S/N 758

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code MCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)