Z-0819-03

Polyflex Esophageal Stent 20/16mm x 120mm

Name: Z-0819-03 Polyflex Esophageal Stent 20/16mm x 120mm
Creator: Boston Scientific Corporation
Published: 2003-04-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-04-16 / Terminated

FDA source

Boston Scientific Corporation began a recall of Polyflex Esophageal Stent 20/16mm x 120mm on 2003-04-16. The reason FDA records is "Radiopaque marker bands may not be visible under fluoroscopy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0819-03
Status: Terminated
Initiated: 2003-04-16
Posted: 2003-05-14
Terminated: 2004-07-20
Recalling firm: Boston Scientific Corporation
Product: Polyflex Esophageal Stent 20/16mm x 120mm
Product code: ESW Prosthesis, Esophageal
Reason for recall: Radiopaque marker bands may not be visible under fluoroscopy
FDA root cause: Other
Action: Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory.
Quantity in commerce: 1
Distribution: Nationwide
Product codes and lots: Reorder Number: M00514280 Lot Numbers: 03101, 03071

Product code ESW

K010068Class IIRusch Polyflex Stent for the Esophagus with Introducer SystemRusch Intl. / cleared 2001-02-08

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)