Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M0015530

FDA device recall Z-2141-2008 · posted 2008-08-13 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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

Action taken

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

Status

Terminated

Product code

NIM

Quantity affected

1946 units (1570 U.S., 376 OUS)

Distribution

Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania,

Date initiated

2008-06-06

Date posted

2008-08-13

Date terminated

2011-02-16

Location

Maple Grove, MN