St. Jude Medical Inc., maker of devices to treat heart conditions, said its Riata defibrillator leads have a higher failure rate than was known last year when it stopped selling the product.
Riata has an insulation failure rate of 0.63 percent, more than the 0.47 percent disclosed last December, the St. Paul, Minnesota-based company wrote in a letter to doctors dated yesterday. The statistics are based on returns and complaints related to the 277,000 wires sold in the past nine years, an approach known to underestimate failure rates, the company said.
