Ventak Prizm 2 DR Model 1861 implantable defibrillator tagged in patient death. May 25, 2005: Guidant Corp. reports 26 cases of failure, including the death of a young Minnesotan — from its Ventak Prizm 2 DR Model 1861 implantable defibrillator. The advisory coincides with a New York Times article saying the company waited years to warn physicians about problems with Guidant defibrillators.
June 17: Guidant voluntarily issues a worldwide safety advisory for seven types of defibrillators.
June 24: Guidant issues a second worldwide safety advisory, warning doctors to discontinue use of five models of defibrillators.
July 1: The Food and Drug Administration classifies Guidant’s safety advisories as recalls.
July 18: Guidant warns doctors that nine pacemaker models made between 1997 and 2000 may need to be replaced.
Recommended to fix flaws in some defibrillators actually increased the chances of malfunctions
July 22: Guidant says a programming change it had recommended to fix flaws in some defibrillators actually increased the chances of malfunctions in three models.
Aug. 1: The FDA approves the relaunch of Guidant’s top-selling defibrillator, the Contak Renewal 3.
Sept. 22: Guidant issues recalls or safety advisories for nearly 170,000 of its top-selling Insignia and Nexus pacemakers. It notifies doctors the failure rate for two defibrillators — the Contak Renewal and Contak Renewal 2 — was nearly triple what it had earlier estimated.
Sept. 29: Citing sources it did not name, the New York Times reports the FDA has started a criminal investigation of Guidant.
Oct. 25: U.S. attorney’s offices in Boston and Minneapolis issue subpoenas to Guidant, Fridley-based Medtronic and Little Canada-based St. Jude Medical for an inquiry into possible violations of “anti-kickback” and “false claims” statutes and whether doctors and clinics received inducements to use the devices.
Nov. 3: New York Attorney General Eliot Spitzer sues Guidant, alleging the company concealed information about a design flaw in a defibrillator.
Jan. 24, 2006: The U.S. attorney’s office in Minneapolis subpoenas Guidant for records disclosed in a Texas lawsuit that indicate the company knew that some heart devices could catastrophically fail.
Feb. 23: FDA inspectors cite Guidant’s Arden Hills plant for failing to correct quality problems and belatedly notifying regulators about a design change in implantable defibrillators.
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