Guidant Device Recall

GUIDANT - FDA Action on defective defibrillators

Gudiant FDA recall - recall lawsuits at Monheit.com

Gudiant FDA recall - recall lawsuits at Monheit.com

Guidant FDA Recall for problems with Guidant Defibrillator.
What are the problems with the Guidant defibrillator that led to the recall?

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Guidant FDA Action - What led to the recall of Guidant's defibrillator?


The FDA requested that Guidant Corporation notify health care providers and patients of the recall of a number of its implantable defibrillators and cardiac resynchronization therapy defibrillators.

In response, not merely once, but on multiple occasions, Guidant has revealed, in a series of notices to doctors and to the public, that many different models of its defibrillator have defects.


Guidant Defibrillator Recall


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ALERT: Deaths Caused by Powerheart, Cardiovive, CardioLife, Recall, Cardiac Science Corporation AED Devices

 

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The news of these problems has come in three waves. More may follow. It all depends on whether Guidant has come clean and told everything it knows, or whether the pattern of this information trickling out will continue.

There have been two deaths reported to FDA suspected to be associated with this malfunction. The devices affected by this notification are: PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002 CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004 CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.

  • Breaking News: On 07/29/2005, Guidant Corporation advised healthcare professionals by letter dated July 22 that one the safety recommendations made to physicians on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK RENEWAL AVT implantable cardioverter defibrillators (ICDs) may significantly increase the risk to patients.
    • As a result, physicians are advised to schedule follow-up visits as soon as possible for patients with devices reprogrammed as per Guidant's original instructions and for all patients with Atrial Episode Data Storage programmed to less than 20%.
  • UPDATE 07/01/2005 FDA updated consumers and patients with additional information on the relative health risks of the now 11 devices affected by this recall. Initially, there were disclosed to be only 7 devices involved.
  • 06/21/2005 FDA Notice: Guidant Corporation notified health care providers and patients of the recall of certain implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices, surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm), can develop an internal short circuit without warning, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event. There have been two deaths reported to FDA suspected to be associated with this malfunction. The devices affected by this notification are: PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004; CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

Ask a Lawyer: Do I have a Guidant Defibrillator Recall Lawsuit?

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What complications have you had from the Guidant defibrillator implant?
For What recommendations have your doctors made about removing this device?
For Please list any relevant Surgeons, Hospitals, and Cardiologists who are treating or have treated you with respect to the Guidant implant. (Please include city & state)
Implant Date: What was the date you received your implant?
If removed, what was the date of REMOVAL of your implant?
Which manufacturer's device has been implanted? (please check all that apply)
GUIDANT
MEDTRONIC defibrillators
Which device(s) have been implanted? (see ID Card for Model #) (please check all that apply)
Ventak Prizm 2 DR (Model 1861), prior to April 16, 2002
Contak Renewal (Model H135), prior to Aug. 26, 2004
Contak Renewal 2 (Model H155), prior to Aug. 26, 2004
Ventak Prizm AVT
Vitality AVT
Renewal 3 AVT
Renewal 4 AVT
Medtronic Concerto
Unknown or Other
Additional Guidant Recall Lawsuit Information: Please be specific and tell us about your experience with the Guidant Defibrillator. Also enter any questions or comments in this space.
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