Guidant Defibrillator, Pacemaker and Ancure Stent-Graft Recall Timeline

The following is a summary of key events in the Guidant device recalls and warnings.

March 2001 - Ancure Device Pulled from Market
Endovascular Technologies, a subsidiary of Guidant, withdraws the Ancure endograft device from the market. Endovascular Technologies admits that it had failed to submit 2,628 incidents of device malfunctions and injuries to patients during surgery to insert it out of a total of 7,632 medical devices sold. Among the unreported incidents were 12 deaths and 57 emergency operations performed when the device's delivery system became stuck in the patient's body.

June 12, 2003 - Charges Filed Against Guidant Subsidiary Concerning Ancure Device
Federal prosecutors charge Endovascular Technologies with 10 felony counts, including false statements to the Food and Drug Administration (FDA) in connection with the Ancure device. The complaint filed alleges that the Ancure device often malfunctioned and Guidant asked doctors to use it in waays not approved by the government. Endovascular Technologies pleads guilty to the charges.

June 16, 2003 - Guidant Announces It Will Stop Making Ancure Endograft System
Nearly two years after reintroducing the Ancure device in August 2001 with FDA-approved modifications in the device's warnings to customers and instructions to doctors, Guidant announces that it would stop making the Ancure Endograft System.

May 23, 2005 - Guidant Issues Safety Advisory Concerning Defibrillator
Guidant issues a safety advisory about certain models of its heart defibrillator, reportedly after the company learned an article by the New York Times was being prepared claiming that Guidant did not tell doctors or patients for three years that the device contains a flaw.

June 1, 2005 - Lieff Cabraser Files Lawsuit Against Guidant
Lieff Cabraser files a lawsuit against Guidant Corporation in federal court in Indianapolis, Indiana, on behalf of a proposed nationwide class of patients implanted with the Guidant Ventak Prizm defibrillator. This was the first lawsuit filed against Guidant based on its faulty defibrillator. The complaint alleges that Guidant misrepresented the safety of its defibrillator, which is subject to short circuiting and malfunctioning.

	Our Guidant defect lawyers have years of experience successfully representing patients with faulty or defective medical implants.
	There is no charge or obligation for our review of your case.
	We are pleased to visit Guidant patients, or families of loved ones who died, at or near where you live and at no cost, to discuss your legal rights and answer your questions.
	To assist our clients with their claims, we have on staff nurses with cardiac training and have retained physicians to provide expert advice.

June 17, 2005 - Guidant Announces Recall of Nearly 50,000 Defibrillators
Guidant announces recall of cardiac defibrillator devices. Advisory states that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. The recall includes the Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155).

June 24, 2005 - Guidant Expands Defibrillator Recall
Guidant announces an additional 46,000 defibrillator devices are potentially defective. Advisory includes all serial numbers of its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF defibrillator devices.

July 1, 2005 - FDA Classifies Defibrillator Recall as Class I
FDA classifies the recall of certain Guidant defibrillator models as a Class I recall, the most serious level of product recall. The models given Class I status include: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The models given Class II status, meaning that any injury caused by a malfunction should be temporary or reversible, include: Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF.

July 18, 2005 - Guidant Alerts Physicians to Potential Flaw in Pacemakers
Guidant issues safety advisory for the Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR pacemaker devices, alerting physicians and patients that the sealing component in the pacemakers can degrade, resulting in higher-than-normal moisture in the devices and possible malfunction.

July 22, 2005 - Guidant Updates Original Recommendations to Physicians
Guidant announces that a software fix for recalled defibrillators it had recommended on June 17, 2005, to prevent possible device failure did not appear to solve the problem and can significantly increase the risk to patients

September 22, 2005 - Guidant Recalls some Insignia and Nexus Pacemakers
Guidant issues a recall for some of its Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization. Guidant said that as of September 6, 36 out of 49,500 devices experienced loss of pacing output, while 16 out of 341,000 devices suffered a telemetry failures.

About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a 50-plus attorney law firm with offices in San Francisco, New York and Nashville. For each of the last six years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs’ law firms in America.

For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned an individual lawyer. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys. To learn more about our firm, click here.

Ortho Evra, Auto Switch Fires,
Car Accidents, Aviation Law, 15-Passenger
Van Accidents, SUV Rollover Crashes

     Additional Lieff Cabraser Information: Lieff Cabraser Heimann & Bernstein, LLP, with offices in San Francisco, New York and Nashville, is one of the largest law firms in the United States that only represents plaintiffs. We have been nationally recognized for our representation of shareholders in cases alleging violations of federal securities laws by major corporations and their directors and officers.
    Our clients come from across America, including the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming. Learn more about our firm.
     Disclaimer: The hiring of legal professionals is an important decision that should not be based on advertising alone. Please read our disclaimer.
     Trademark Notice : The law firm of Lieff Cabraser Heimann & Bernstein, LLP, is in no way affiliated with Guidant Corporation or Endovascular Technologies, and any use of trademark information is for reference and informational purposes only.