Z-0806-2010

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit...

Name: Z-0806-2010 Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit...
Creator: Merit Medical Systems, Inc.
Published: 2010-01-28
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-01-28 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095... on 2010-01-28. The reason FDA records is "Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0806-2010
Status: Terminated
Initiated: 2010-01-28
Posted: 2010-02-22
Terminated: 2010-04-27
Recalling firm: Merit Medical Systems, Inc.
Product: Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
FDA 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 in commerce: 51 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.
Product codes and lots: Lot Numbers: F727583A, IML4453A, IML4487A, IML4488A and IML4533A.

Product code FGE

K072720Class IIAlimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc. / cleared 2008-04-11

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)