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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.
 
Guidant heart devices
Guidant heart device defects and lawsuits
Guidant - Ancure Device Defects
Information on the Ancure heart device, defects & lawsuits

Guidant - Defibrillator Defects
Information on Guidant defibrillators, defects & lawsuits

Guidant - Pacemaker Defects
Information on Guidant pacemakers, defects & lawsuits

Guidant Heart Devices Timeline
Chronological information on defects and lawsuits relating to Guidant heart devices


FDA Warning Information on Guidant Heart Devices
Warning letters and doctor and patient guidelines for Guidant devices
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.
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     About Lieff Cabraser: We have offices in San Francisco, New York and Nashville. Our lawyers have represented clients in personal injury, wrongful death and rollover crashes and product defect lawsuits across America, including residents 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.
     Among the cases our personal injury attorneys are prosecuting are the Medtronic heart lead recall, the AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant pacemaker defects, SUV rollover accidents, popcorn workers lung injuries, and Ford switch fires.
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