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.