On
June 17,
2005,
Guidant Corporation issued a recall of three models of its Cardiac Defibrillators: (1) the Contak Renewal, Model H135; (2) the Contak Renewal 2, Model H155, and (3) the Ventak Prizm 2 DR, Model 1861. The recall included all Contak Renewal and Contak Renewal 2 devices manufactured up to
August 26, 2004
, and all Ventak Prizm devices manufactured before April, 2002. One week later, Guidant extended the recall to include the Contak Renewal 3 and 4, Contak Renewal 3 and 4 AVT, and Contak Renewal RF implantable cardioverters.
On
July 1,
2005,
the F.D.A. designated the Contak Renewal, Contak Renewal 2 and Ventak Prizm recalls as "Class I" recalls which, according to the FDA, “are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.” On that same date, the FDA also designated eight other models of Guidant Defibrillators and pacemakers as "Class II" recalls, which pose a somewhat lessened but still serious risk.
Sacks & Weston represents patients who have been implanted with Guidant cardiac defibrillators and pacemakers. If you or a family member have been implanted with one of the affected devices, and wish to discuss your legal rights, please contact us using the form below, or call 800-578-5300. There is no cost or obligation for such inquiries, and any information you provide will be held in strictest confidence.