2017-06-21T21:35:01+00:00Pritzker Hageman, P.A.
45 S 7th St, #2950
Minneapolis, MN, 55402
U.S.A
+1.612.338.0202

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

Attorney David Szerlag
Attorney David Szerlag represents people injured by defective medical products and families with wrongful death claims.

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:

  1. 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/