Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
FDA Recall Z-2141-2008 · Posted 2008-08-13
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeNIM
Date Initiated2008-06-06
Date Terminated2011-02-16
Product Quantity1946 units (1570 U.S., 376 OUS)
Reason for Recall
Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip.
Since the potential for the tip to detach occurs during delivery of the sten
Firm Action
Boston Scientific sent an urgent Voluntary Medical Device Recall letter, dated 06/06/08, to affected customers. The letter described the issue, identified affected product, requested to cease using or distributing the product and provided direction on how to return the recalled devices to Boston Scientific, Quincy, MA. A Reply Verification Tracking Form was asked to be returned to Boston Scientific. Since the issue is with the delivery system, patients already implanted with the stent are not affected.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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