The FDA slaps St. Jude's now-defunct Riata device with Class I status after the company announces the defibrillator leads failed more often than previously reported.
The FDA slapped St. Jude Medical Inc.'s (NYSE:STJ) Riata with a Class I recall after the company said the defibrillator leads failed more frequently than previously reported.
Two patients died and another suffered a serious injury when surgeons attempted to extract the leads, the company said. Another patient died and a fifth was seriously injured, both with compromised Riata leads, but the "externalized conductors" were not found to be responsible, St. Jude added. The Class I status is the federal watchdog agency's most serious category, reserved for products with a potential risk of serious injury or death.
"Externalized conductors" refers to lead wires poking through their insulation, potentially delivering unwanted shocks to patients. The St. Paul, Minn.-based med-tech titan announced last week that the leads were more prone to "insulation abrasion" than it had reported in the past.
The company issued a physician advisory letter late last month warning that Riata has had a 0.63% failure rate over the last 9 years. The new figure was based on returns and complaints about the devices, a method that St. Jude acknowledged as known to underestimate the true failure rate.
News of the higher failure rate led Jeffries analyst Raj Denhoy to downgrade St. Jude from "buy" to "hold" on concerns that Riata will have a continued negative impact on sales through 2012. Denhoy also lowered his price target for STJ stock to $38 from $40 in a research note to investors earlier this week.
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