More Product Safety Issues for Guidant
By Erik Ricasa
Published on July 22, 2005
Nine models are involved in the alert: the Pulsar Max, the Pulsar, the Discovery, the Meridian, the Pulser Max II, the Discovery II, the Virtus Plus II, the Intellis II, and the Contak TR. The devices, which were manufactured from 1997-2000, are still implanted in patients.
According to the company, moisture build up may cause product failure and "serious health complications" in some patients. The U.S. Food and Drug Administration is reviewing the alert, which follows Guidant's recent recall of more than 50,000 implantable heart defibrillators.
The safety problems come at an unfortunate time for the company, which is in talks to be purchased by Johnson & Johnson later this year.
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