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Practice Areas | Guidant
Defibrillator Recall
On June 17, 2005, the U.S. Food and Drug Administration ("FDA") notified doctors, patients and the public that Guidant Corporation, a manufacturer of medical devices, is recalling approximately 50,000 of its implantable defibrillators and cardiac resynchronization defibrillators. ICDs are surgically implanted in patients who suffer from cardiac arrhythmias and are designed to regulate an abnormal heart rhythm by generating a shock to the heart (defibrillation).
On June 23, 2005, Guidant announced a second recall of some 46,000 additional defibrillators. This second recall involves different models than the first recall and a different type of defect. On June 23, 2006, Guidant issued yet another notice about device malfunctions that could affect thousands of its defibrillators.
In addition to these recalls and warnings, Guidant has also notified the FDA that certain models of its other defibrillators are subject to a memory error. The FDA is currently reviewing this information.
The Reasons for the Recalls
The first recall is required because without warning, each of the models involved can develop an internal short circuit that could cause the device to fail and prevent it from delivering the life-saving heart defibrillation it was designed to provide. According to Guidant, "…there is no means of predicting whether any particular device will in fact fail."
The second recall is required because each of the defibrillator models involved has a magnetic switch that can become stuck in the closed (off) position and prevent the device from delivering its potentially life-saving shock to the patient.
The Models Recalled
The Guidant defibrillators which are being recalled are the following:
- VENTAK 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
- CONTAK RENEWAL 3
- CONTAK RENEWAL 4
- RENEWAL RF
- RENEWAL 3
- RENEWAL 4 AVT
Guidant has also notified the FDA that it is recalling additional models of its defibrillators which are subject to a memory error. These models are:
- PRIZM AVT
- VITALITY AVT
- RENEWAL 3 AVT
- RENEWAL 4 AVT.
First Indications of the Defect involved in the First Recall
According to published reports, Guidant knew about the risk of device failure for three (3) years before it notified doctors and the FDA of the defect. It wasn't until March, 2005 - when a 21 year old college student died after his PRIZM 2 defibrillator short-circuited - that Guidant issued a warning concerning the risk of failure.
The Scope of the Recalls
According to information supplied by Guidant, there are approximately 50,000 defibrillators in service worldwide that are subject to the June 17, 2005 recall. Of these, approximately 38,600 are in the United States. For the three models that are at risk of developing an internal short-circuit - VENTAK PRIZM 2 DR, MODEL 1861, CONTAK RENEWAL, MODEL H135 and CONTAK RENEWAL 2, MODEL H155, there are approximately 20,600 of these defibrillators in service in the United States.
The second recall involves an additional 46,000 defibrillators of which Guidant estimates 40,000 have been implanted in patients and 6,000 are in the marketplace awaiting implantation.
FDA Classification of the Recalls
On July 1, 2005, the FDA announced that it classified the Guidant recalls based on the FDA's "evaluation of the safety and performance of…" the Guidant defective defibrillators. The FDA's classification affects 11 different models of the Guidant ICDs and CRTs - dividing them into either a Class 1 or Class 2 recall grouping. A Class 1 recall is the most serious of the FDA's recall grouping and applies when "…there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning will cause serious adverse health consequences or death."
In a Class 2 recall, "the malfunctioning product may cause temporary or medically reversible adverse health consequences, however, the probability of serious adverse health consequences is remote. The models assigned to the Class 1 recall group are:
- VENTAK PRIZM 2 DR - Model 1861 - manufactured on or before 4/16/2002
- CONTAK RENEWAL - Model H 135 - manufactured on or before 8/26/2004
- CONTAK RENEWAL 2 - Model H 155 - manufactured on or before 8/26/2004.
The models assigned to the Class 2 recall group- for a memory defect - are:
- VENTAK PRIZM AVT - Model 1900
- VITALITY AVT
- RENEWAL AVT.
Other models assigned to the Class 2 recall group - for a magnetic switch failure - are:
- CONTAK RENEWAL 3
- CONTAK RENEWAL 4
- RENEWAL 3
- RENEWAL 4 AVT
- RENEWAL RF
If you or a loved one has or had a defective defibrillator or pacemaker, please click HERE for information about potential claims against the manufacturer and one's legal rights.
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