June 18, 2005
At FDA's Urging, Guidant Recalls 29,000 Heart Devices
Guidant Corporation is recalling 29,000 heart devices because of flaws that may cause them to malfunction when they are supposed to deliver a potentially life saving electrical shock to the heart. The three defibrillator devices manufactured by Guidant came under FDA scrutiny during their review of Guidant's handling of issues surrounding the three products particularly the Prizm 2 DR. The other two models are the Contak Renewal and the Contak Renewal 2. Guidant did not tell doctors for more than three years that the product (Prizm 2 DR) was prone to electrical failure due to a design flaw. Guidant also disclosed yesterday that the other two products were prone to the same failure. The company said it was aware of two recent deaths involving the units at issue.
