Guidant defibrillators, also called Implantable Cardioverter Defibrillators or ICDs, are implanted into patients with congestive heart failure, abnormally fast heart rhythms/ tachycardia or irregular heartbeats, and are designed to shock a faltering heart. According to the American Heart Association, 64,000 implantable defibrillator operations are performed on U.S. patients each year. Approximately 24,000 defective Guidant ICDs have been implanted in U.S. patients.
In June of 2005, Guidant Corporation recalled thousands of their Implantable Cardioverter Defibrillator (ICD) due to a manufacturing defect that may cause the device to short-circuit or malfunction. It is alleged that Guidant knew of the problems with their heart defibrillators and failed to publicly disclose the life-threatening defects until FDA intervention and public scrutiny.
These popular ICDs are implanted into patients with congestive heart failure, abnormally fast heart rhythms/ tachycardia or irregular heartbeats to shock their faltering heart. According to the American Heart Association, 64,000 implantable defibrillator operations are performed on U.S. patients each year. Approximately 24,000 defective Guidant ICDs have been implanted in U.S. patients.
The initial defibrillator in question was the Ventak Prizm 2DR, Model 1861, manufactured on or before April 16, 2002. Although the recall has periodically expanded to include additional models, the recall list presently includes the following models:
- VENTAK PRIZM 2 DR (Model 1861)
- VENTAK PRIZM AVT
- CONTAK RENEWAL (Model H135)
- CONTAK RENEWAL 2 (Model H155)
- VITALITY AVT
- RENEWAL 3 AVT
- RENEWAL 4 AVT
Further investigation by Guidant and the FDA has uncovered more reports of device failures and deaths linked to Guidant ICDs. To date, Guidant has recalled or issued warnings for over 80,000 heart defibrillators, including its best-selling Contak Renewal 3.More About Guidant Recalls Class I Guidant Recall: PRIZM 2 DR, CONTAK RENEWAL, CONTAK RENEWAL2
In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.Class II Guidant Recall: VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices, CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices
In a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences. These Guidant devices are said to be subject to a memory errors.Accusations Against Guidant
Currently, Guidant faces over 100 individual and class action lawsuits related to its defibrillator and pacemaker products. Guidant may also face a civil lawsuit by the federal government for failure to disclose its product's potentially fatal defects. Medical professionals and legal professionals believe that Guidant withheld pertinent information about defibrillator malfunctions and mechanical design defects. It is alleged that Guidant learned of their ICDs life-threatening defects in 2002 but did not disclose this information to the public until 2005 while heavily marketing their products worldwide.
Guidant designs, manufactures, and distributes products focused on the treatment of cardiac arrhythmia, heart failure and coronary and peripheral disease.
Medical professionals advise that if you have a Guidant defibrillator, talk to your doctor as soon as possible to find out more about your medical risks and options.
If you have the device implanted, had the device replaced or plan to have it replaced, whether or not you suffered complications from at this time, you may be entitled to compensation.
- Guidant reveals two repairs made to the Ventak Prizm 2 in 2002 that did not receive approval by the FDA. This admission means that Guidant may have been breaking a federal law by manufacturing and marketing an unapproved defibrillator. (Feb-22-06) [MSNBC ]
- FDA Update on Guidant ICD recall: Prizm and Contak Renewal implantable defibrillators. (Oct-13-05) [FDA ]
- New FDA Study reveals that between 1990 and 2002 over 17,000 pacemakers and implanted Cardioverter defibrillators, or ICDs were surgically removed due to device malfunctions. (Sep-16-05) [MSNBC ]
- Family learn about cardiac defibrillator recall after father's death. (Jul-15-05) [FIRST COAST NEWS ]
- The has FDA put a severe rating on two makes of Guidant implantable defibrillators that have been recalled. The models designated are the Ventak Prizm 2 DR and the Contak Renewal 1 and Contak Renewal 2. The recall of these devices is considered of the highest priority. (Jul-01-05) [INVESTORS.COM ]
- Guidant Corp. recalls 50,000 defibrillators after finding that flaws in the devices were more far reaching than had been disclosed in the previous month. (Jun-17-05) [INDIANAPOLIS STAR ]
- FDA announces Guidant Corporation's recall of implantable defibrillators and cardiac resynchronization therapy defibrillators. (Jun-17-05) [FDA ]
If you or a family member has a defective or recalled Guidant defibrillator implanted, you may qualify for damages or remedies by making a claim or filing suit against the manufacturer. Please fill out the Guidant case-evaluation form, or call Hollis Wright toll-free at 1-844-529-8255. Your case will be evaluated for free, and we will let you know whether you have a valid case against the manufacturer.
Click here to complete our free evaluation form, and submit your case to Hollis Wright for a free and confidential case-review and consultation.