After 3 patient deaths, Boston Scientific Corporation issued a voluntary recall of an older version of its Lotus transcatheter aortic heart valve replacement system, according to news reports (1). “Catastrophic vessel trauma” was associated with these deaths.
Recall Information
The recall involves 250 products, manufactured before March 2016, that have not been implanted in patients. Of the 250, 15 are in the United States. This is because the Lotus valves have only been used for clinical trials here.
The recall was issued because a component of the Lotus valve system called the release mandrel “may break when the device is being implanted” (1). This component is not left inside of the body after the procedure, according to the company, so Lotus valves that have already been implanted are not affected by the recall.
Boston Scientific has offices in Minnesota.
Minnesota Law Firm
Our law firm, which has offices in Minneapolis, Minnesota, is investigating this recall. Attorney David Szerlag, of Counsel, helps families pursue wrongful death lawsuits against companies that sell defective products. He has won millions for his clients. David can be contacted at 612-338-0202 or 1-88-377-8900 (toll free).
Sources:
- Carlson, Joe. “Boston Scientific issues voluntary recall of Lotus valve system.” http://www.startribune.com/boston-scientific-issues-voluntary-recall-of-lotus-valve-system/389350631/