Boston Scientific (NYSE:BSX) this week issued a voluntary field safety corrective action for its Lotus Valve Systems, looking to recall units from the field over issues with release mandrel breakage.
The company is looking to “remove units from the field” that were manufactured prior to a component related change made in March this year, and specified that units manufactured after the change was implemented are not affected.
The release mandrel is a delivery system component connected to the release pin which allows the valve to release from the delivery system.
Boston Scientific said it received a number of release mandrel break reports, with the most common outcome being resheathing and removing the device “without difficulty” which resulted most commonly in procedural prolongation, according to a press release from the company.
The company said it received 3 more severe cases in which catastrophic vessel trauma associated with patient death was reported.
Boston Scientific identified UPNs H749LTV230, H749LTV250 and H749LTV270 as affected by the recall, with a full list of affected lot numbers listed on the safety notice.
Boston Scientific instructed customers with affected items to remove them from inventory and contact the company to arrange for a return.
The post Boston Scientific issues urgent field safety notice for select Lotus valves appeared first on MassDevice.
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