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Terminated

Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

FDA Recall Z-0358-2011 · Posted 2010-11-15

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2009-08-24
Date Terminated2011-02-03

Reason for Recall

Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.

Firm Action

Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.

Root Cause

Packaging process control

Distribution Pattern

Distribution Worldwide, including throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973645RENEGADE FIBER BRAIDED MICROCATHETERBoston Scientific Corp · 1997-11-19

Official Source

View FDA Recall →

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

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