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If you have questions regarding a possible claim, or would like to speak with an attorney regarding your rights, please fill out our "Guidant Defibrillator Recall " form below.
Once you submit your information below, your free consultation form will be sent to a sponsored Massachusetts lawyer handling your field of law, for evaluation. That lawyer will review your form in accordance with the site terms and conditions.
GUIDANT DEFIBRILLATOR
FDA ISSUES NATIONAL RECALL ON GUIDANT CORPORATION’S IMPLANTABLE DEFIBRILLATORS
THE FOLLOWING ARE THE 11 DEVICES AFFECTED BY THE RECALL:
· GUIDANT DEFIBRILLATORS
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
· VENTAK PRIZM AVT
· VITALITY AVT
· RENEWAL AVT
· CONTAK RENEWAL 3 and 4
· RENEWAL 3 and 4 AVT
· RENEWAL RF
GUIDANT DEFIBRILLATOR RECALL
Guidant has determined that the defect may be linked to a hermetic sealing component used in the subset of devices listed above which may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.
As of july 11, 2005, Guidant has identified sixty-nine (69) devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time.
Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.
The clinical behaviors associated with this failure mode can result in serious health complications.
· Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization.
· Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died.
If you or or a loved one has been injured by a defective guidant defibrillator you may be entitled to monetary compensation. Completre the form below for a free evaluation of your claim by an attorney. There is no cost or obligation for this service.
There is no cost or obligation for this service. This form will be sent to:
Attorney Donald Grady, Jr.
Sheff Law Offices
10 Tremont Street, 7th Floor
Daniel Webster Suite
Boston, MA 02108
617-227-7000
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