Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 90mm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polyflex Esophageal Stent 25/21mm x 90mm
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Reorder Number: M00514330 Lot Numbers: 03101, 03071
Products Sold
Reorder Number: M00514330 Lot Numbers: 03101, 03071
Boston Scientific Corporation is recalling Polyflex Esophageal Stent 25/21mm x 90mm due to Radiopaque marker bands may not be visible under fluoroscopy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Radiopaque marker bands may not be visible under fluoroscopy
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026