NEW YORK ( TheStreet) -- Boston Scientific ( BSX) is down more than 16% in premarket trading Monday after reports that Boston Scientific is holding off sales and use of its entire line of ICD cardiac devices indefinitely because of a "documentation error" in its U.S. Food & Drug Administration filing.

Marketwatch cites the researchers as saying that "the problem appears to be documentation-related only and there have not been any reports of quality issues or patient safety concerns."

Meanwhile, a long-term study performed in Korea of more than 2,000 patients at 12 centers to find out whether stents could be an alternative to bypass surgery for a clogged, main artery in the heart, has shown results similar to that of bypass surgery for the patient's survival, while increasing the chances of the patient requiring further procedures, according to Dow Jones Newswires. The data was presented Sunday at the American College of Cardiology's yearly conference.

Shares of Boston Scientific, a major stent manufacturer, have plunged more than 16% to $6.50 in pre-market trading.

In the first week of February it was announced that some longstanding patent disputes between Boston Scientific and Johnson & Johnson ( JNJ) were finally resolved, with J & J emerging as the clear winner.

-- Reported by Andrea Tse in New York

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