Teaching Brief - MedPage Today
INDIANAPOLIS, June 17-The Guidant Corp. here has agreed with the FDA to recall 38,000 potentially flawed implanted heart defibrillators, the company said today.
The recalled models are the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
The company said that it was voluntarily advising physicians "about important safety information regarding certain devices." These actions the FDA defined as recalls, Guidant said.
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