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Terminated

Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA

FDA Recall Z-0482-2011 · Posted 2010-11-26

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNJE
Date Initiated2010-03-01
Date Terminated2010-11-26
Product Quantity638 units

Reason for Recall

The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used.

Firm Action

Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form. Customers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary, India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.

Official Source

View FDA Recall →

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

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