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Which Guidant cardiac defibrillator was implanted?

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Guidant Defibrillators

Guidant Defibrillators Side Effects Lawsuits | Side Effects: Injury, Death | Device Malfunction, Premature Battery Depletion, Faulty Product

Guidant Defibrillators Side Effects May Result In Personal Injury Lawsuits

Guidant Defibrillators | Lawsuits, Lawyers | Side Effects: Injury, Death | Device Malfunction, Premature Battery Depletion, Faulty Product

On April 5, Boston Scientific/Guidant recalled approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices may cause the batteries to deplete sooner than expected. Most patients will not be affected by this recall, but patients with one of the recalled devices should contact their physicians about what steps to take next. Please see the questions below for additional information.

What exactly is affected by this Boston Scientific/Guidant recall?

The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).

What is the problem with these devices? A capacitor in the affected devices could malfunction, leading to premature battery depletion.

How serious is this? As of March 30, 2007, Boston Scientific has confirmed 19 field events with Guidant’s devices, primarily related to premature battery depletion. There were no serious injuries or deaths reported.

On December 14, 2005 Guidant announced that 3 more patients with recalled defibrillators made by Guidant have died, bringing the total number of known deaths linked to the faulty products to seven. Guidant is under investigation by federal and state officials and faces dozens of lawsuits over its recalls. Guidant Corp. on October 14, 2005 told U.S. regulators that they received reports of 6 additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.

The failures were in the Contak Renewal and Renewal 2 models, the FDA said in an update posted 10/13/05 on the agency's website. The two devices were among models included in warnings Guidant sent to doctors in June, which the FDA classified July 1 as recalls. The new reports of failures bring the total worldwide to 21, including three cases in which patients died, Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, said.

Other News

Guidant Corp. has recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly. The Guidant defibrillator defects include short circuiting, problems with the magnetic switch and computer memory problems. The defect that causes short circuiting of the device has caused two deaths to date, including the sudden death in March 2005 of a 21-year-old college student. Following are details of the models affected by the recall and the follow-up advisory:

2005 Recall

June 16, 2005 - Guidant recalled 50,000 defibrillator devices including the following models:

  • Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002
  • Contak Renewal, Model H135, manufactured on or before Aug. 26, 2004
  • Contak Renewal 2, Model H155, manufactured on or before Aug. 26, 2004
  • Prizm AVT Vitality
  • Renewal 3 AVT
  • Renewal 4 AVT

June 24, 2005 - Guidant issued an advisory about additional defibrillator devices including the following models:

  • Contak Renewal 3 and 4
  • Renewal RF

Guidant claims that it discovered the short circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety.

Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine if their model requires replacement, if their device can be reprogrammed, or if their device is not affected by the recently announced safety issues.

2006 Recall

On June 26, 2006, the FDA and Guidant informed all patients and medical professionals that Guidant’s Ventak Prizm 2, Vitality and Vitality 2 Implantable Cardioverter Defibrillators have been associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients who have these particular ICD devices may experience inappropriate sensing or early battery depletion.

Legal Help For Victims Affected By Guidant Defibrillators

If you or a loved one suffered injuries from a Guidant Defibrillator, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


Guidant DefibrillatorsRSS Feed

Changing ICD generator elevates risk factor for Sprint Fidelis lead failures

Jun 18, 2012 | Parker Waichman LLP
Patients relying on an implantable cardiac defibrillator (ICD) are more likely to experience malfunctions and failures with the Sprint Fidelis leads connecting it to the heart if they change the device's generator. According to a report at, new research from Emory University identified changing the generator on an ICD device while keeping the Sprint Fidelis leads would likely lead to a device failure. The Sprint Fidelis lead was recalled in 2007 following scores of reports of its...

Doctors Who Brought Guidant Defibrillator Problems to Light Ask Judge to Reject Plea Agreement

Apr 22, 2010 | Parker Waichman LLP
 Drs. Robert Hauser and Barry Maron, both prominent cardiologists, have asked a federal judge to reject the plea agreement the government struck with  Boston Scientific’s Guidant unit for withholding information about faulty defibrillators from federal regulators. According to New York Times, both doctors were instrumental in bringing the Guidant defibrillator problems to light in 2005. They had cared for a 21-year-old college student who died when his implantable defibrillator...

Judge Delays Approval of Boston Scientific Guidant Defibrillator Settlement

Apr 6, 2010 | Parker Waichman LLP
Boston Scientific's proposed plea agreement with the federal government over faulty Guidant defibrillators may be in jeopardy. Lawyers for people implanted with the potentially defective implantable defibrillators are seeking a portion of the $296 million settlement. Plaintiffs lawyers convinced a federal judge yesterday to delay approval of a deal that would have resolved federal criminal charges against the company. Yesterday’s hearing in U.S. District Court in St. Paul, Minnesota...

Recall for Boston Scientific Implantable Defibrillators

Mar 16, 2010 | Parker Waichman LLP
A massive recall is being issued for seven brands of Boston Scientific implantable heart defibrillators.  The recall is being issued because Boston Scientific has determined that it did not get approval from federal regulators for changes to its manufacturing processes. According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators...

Boston Scientific Agrees to Pay $22 Million to Settle Guidant Charges

Dec 29, 2009 | Parker Waichman LLP
For the second time in a month, Boston Scientific has settled federal charges related to Guidant Corporation.  Boston Scientific acquired Guidant in 2005.   Last month, the Boston Scientific agreed to pay $296 million to settle another Justice Department probe into Guidant’s handling of heart devices. According to a report in the Pioneer Press, this latest settlement involves allegations that Guidant designed four post-market studies in 2003 and 2004 as a means to increase...

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