FDA slams St. Jude Medical over Durata pacemaker leads
St. Jude Medical shares are down 11% today after the FDA releases a report slamming the company over its Durata pacemaker leads.
The FDA yesterday released a report on a St. Jude Medical (NYSE:STJ) plant in Sylmar, Calif., that makes its Durata pacemaker leads, finding 11 problems with the plant after inspections in September and October.
The news sent STJ shares down more than 11% today as investors reacted to the news. St. Jude released a heavily redacted copy of the report in October, along with its 3rd-quarter results.
Investors are watching closely for signs of problems with the next-generation Durata leads after the St. Paul, Minn.-based medical device company recalled some of its Riata leads last year. Last month CEO Daniel Starks cautioned that St. Jude risked a warning from the federal watchdog agency over the Sylmar plant.