Boston Scientific Corp. (BSX) in Natick is voluntarily recalling certain lots of its Mach 1 Guide Catheter in the U.S., due to risks presented by excess resin near the hub of the guide catheter.
Though only present in some product units, strands of the resin could potentially obstruct a blood vessel, resulting in complications such as stroke, heart attack, or kidney problems. At this time, no product complaints related to this issue have been lodged with Boston Scientific.
The affected products were only released to U.S. hospitals, and BSX is alerting those institutions through recall notification letters requesting that use of the affected products cease immediately. The total number of affected devices is estimated at 51.
Boston Scientific is a developer, manufacturer, and marketer or medical devices.
