Boston Scientific Lotus Valve Recall Issued Following Patient Deaths
Following reports of at least three patient deaths, Boston Scientific has recalled a heart valve replacement system due to a risk that a component may break while the device is being implanted.
A Boston Scientific Lotus Valve System recall was announced last week in a field safety notice (PDF) issued by the company, which indicates that catastrophic vessel trauma has occurred in at least three cases involving the artificial heart valve system, which all resulted in patient deaths.
In addition to the fatalities, Boston Scientific reports that there were a number of release mandrel breaks reported, resulting in the device having to be removed during the implant procedure. The release mandrel is part of the delivery system of the valve. It is connected to a release pin which allows the delivery system to release the Lotus heart valve once it is properly in place.
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The company made a component change in March 2016, which it believes has fixed the problem. There have been no reports of release mandrel breaks since the change was made, according to the field safety notice.
The recall affects Boston Scientific Lotus Valve Systems with UPNs of H749LTV230, H749LTV250, and H749LTV270. A full list of affected lot numbers is available on the field safety notice.
The company says the risk only occurs during the implant procedure. Patients who successfully had the valve implanted are not in any known risk, and the problem has not affected the performance of the valves once properly in place.
Boston Scientific is instructing customers who still have the recalled artificial heart valves in stock to immediately discontinue their use, and remove them from their inventory. The company asked customers to complete a verification form and return it to a Boston Scientific office, and to return any unused products affected by the recall.
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