FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
- Recall number
- Z-0802-2010
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
- Status
- Terminated
- Initiated
- 2010-01-28
- Posted
- 2010-02-22
- Terminated
- 2010-04-27
- Reason
- Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Root cause
- Component change control
- Action
- Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm. For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228.
- Quantity
- 15 units
- Distribution
- Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.
- Lot, serial or model codes
- Lot Numbers: F727579A and IML4457A.
- 510(k) numbers
- ["K072720"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- 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