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SaturdayF.D.A. Says Flaws in Heart Devices Pose High Risks - New York Times
LINK:FREE ONE-TIME REGISTRATION REQUIRED - New York TimesThe Food and Drug Administration said yesterday that potential electrical flaws in some heart devices made by the Guidant Corporation, including one flaw that the company did not tell doctors about for years, posed a risk of serious injury or death to patients.
In its announcement, the F.D.A. designated three models recently recalled by Guidant as "Class I" actions, the highest risk level. It also designated eight other models as "Class II" recalls, or those posing a less serious risk. |
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