Boston Scientific Issues Class 1 for iCross Coronary Imaging Catheters

Boston Scientific Corp. just announced a voluntary Class 1 recall of all unused units of its <"">iCross coronary imaging catheters over a problem with tip detachments, said Mass Device. The recall does not involve patients implanted with the iCross catheter, said Mass Device, which pointed out that the problem occurs when the device is implanted.

Boston Scientific confirmed eight cases in which catheter tip detachments occurred because of “embrittlement,” said Mass Device. The cases were reported between April 1 and May 10 of 2011; some 30,000 catheters have been distributed in the United States and its boundaries. Boston Scientific promised to replace all of the recalled iCross devices with the Atlantix SR Pro Model, at no cost.

Earlier this year we wrote that Boston Scientific’s Guidant unit will pay a record criminal penalty for withholding safety information about its defective implantable heart defibrillators from federal regulators. The defibrillators at the center of the U.S. Justice Department’s criminal prosecution of Guidant Corp. were linked to 13 deaths.

A prior $296 million settlement between the Department of Justice and Boston Scientific was rejected by U.S. District Judge Donovan Frank last April, after some doctors and patients who received implantable defibrillators complained that the company should have faced more sanctions than simply a fine.

The judge approved a new settlement that leaves the $296 million fine in tact, but also called for Boston Scientific to serve three years’ probation. The $296 million penalty is believed to be the largest criminal penalty ever imposed in a medical device case.

Last year, we wrote that Boston Scientific reported problems with more of its implantable defibrillators. According to The Wall Street Journal previously, the company advised physicians that three brands of the devices–Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs–may not work. All of the affected Boston Scientific defibrillators were made in 2006 and 2007 and were implanted in about 34,000 patients.

In an advisory for doctors, Boston Scientific said a magnetic switch on the implantable defibrillators can get stuck, stopping the devices from delivering an electric shock to the hearts of patients who need the therapy. The switch prevents the device from delivering shocks when doctors are performing an emergency procedure on a patient using a magnet that could trigger the defibrillator. Once the magnet is taken away, the switch should open and allow the device to resume normal functioning. According to the advisory, the switch would, in rare instances, stay shut.

This was the third time in less than a year that Boston Scientific had issues with some of its implantable defibrillators. As we reported previously, in March the company recalled seven brands of implantable defibrillators because it did not receive approval from federal regulators for changes to its manufacturing processes. The brands impacted by that recall included: Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality.

That December, Boston Scientific warned that its Cognis and Teligen defibrillators had a design flaw that could result in the devices delivering unnecessary shocks to the small number of patients who had the defibrillators implanted under their chest muscles. The company later said it had fixed the problem.

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