FDA Medical Device Recalls (openFDA)
Elana, Inc.: 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.
- Recall number
- Z-1143-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-02-14
- Posted
- 2013-04-18
- Terminated
- 2013-05-09
- Reason
- Distribution of an unapproved device into interstate commerce.
- 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: Claartje@elana.com 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
- 3 devices
- Distribution
- Distributed in the states of Pennsylvania, Texas, and New York.
- Lot, serial or model codes
- Model 280, S/N 776, S/N 706, S/N 758
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3006784599
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28