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Terminated

Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal Release (18/23/12/9) Material/UPN/Catalog Number: M00513740

FDA Recall Z-2317-2010 · Posted 2010-08-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeESW
Date Initiated2010-07-15
Date Terminated2011-10-14
Product Quantity9 units

Reason for Recall

Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

Firm Action

Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091816ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation · 2009-07-01

Official Source

View FDA Recall →

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

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