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Guidant Makes Prizm 2 DR Recall Official, Adds More Devices To Warning List

This article was originally published in The Gray Sheet

Executive Summary

Guidant will offer free replacements of certain ICD and CRT-D models following the failure of a small number of the devices, but the firm is not recommending substitution across the board

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New York State Attorney General Files Suit Against Guidant, Alleging Fraud

New York State Attorney General Eliot Spitzer joined the parade of plaintiffs suing Guidant over issues related to a potentially lethal design flaw in implantable cardioverter defibrillators

New York State Attorney General Files Suit Against Guidant, Alleging Fraud

New York State Attorney General Eliot Spitzer joined the parade of plaintiffs suing Guidant over issues related to a potentially lethal design flaw in implantable cardioverter defibrillators

Regulatory News In Brief

Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...

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