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 The medical device maker said it received 8 reports related to the
issue out of 7,347 potentially affected units through July 6, but no
reports of "adverse patient effects". (http://bit.ly/1eVphqe)
All affected systems have been withdrawn from the market, Medtronic
spokeswoman Wendy Dougherty told Reuters on Thursday, adding that no
affected loading systems had been released commercially in the
United States.
The U.S. Food and Drug Administration classified the recall as
"Class 1", implying there is a reasonable probability that the use
of or exposure to the product could cause serious side-effects or
death. (http://1.usa.gov/1McR6cs)
The product, EnVeo R Loading System, is part of Medtronic's
CoreValve Evolut R system, which was cleared for marketing in the
United States in June.
The Evolut device is approved for transaortic valve replacement (TAVR)
in patients with severe aortic stenosis — a condition where the
aortic valve narrows — and for whom surgery is too risky.
The presence of particulates could potentially lead to the
introduction of a blockage in the bloodstream, Medtronic said in a
letter to customers.
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The issue has been resolved with improvements in the manufacturing
process, Dougherty said.
Shares of the medical device maker, which bought Ireland-based
Covidien in January for about $50 billion, closed down about 2
percent at $77.41 on the New York Stock Exchange.
(Reporting by Natalie Grover in Bengaluru; Editing by Sriraj
Kalluvila)
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