Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
FDA device recall Z-0482-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NJE
- Quantity affected
- 638 units
- Distribution
- 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
- Date initiated
- 2010-03-01
- Date posted
- 2010-11-26
- Date terminated
- 2010-11-26
- Location
- Fremont, CA
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