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Terminated

Polyflex Esophageal Stent 20/16mm x 90mm

FDA Recall Z-0818-03 · Posted 2003-05-14

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeESW
Date Initiated2003-04-16
Date Terminated2004-07-20
Product Quantity5

Reason for Recall

Radiopaque marker bands may not be visible under fluoroscopy

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010068RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEMRusch Intl. · 2001-02-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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