Guidant Recall Timeline
Guidant medical reports show 45 defibrillator malfunctions, resulting in at least two deaths since May 30, 2005 . More than 38,000 patients throughout the United States rely on the Guidant defibrillators. The first signs of the Guidant malfunction began in 2002, when officials detected a potential problem with the wiring of the VENTAK PRIZM 2 DR (model 1861), and short circuiting. Guidant stated that this flaw would be corrected in future models, so they only began to notify doctors of this potential malfunction in May 2005. Two months later, the FDA issued a voluntary recall.
If you or a loved one has a heart device and has visited a physician due to this recall, contact a heart device attorney to evaluate your potential claim. The recalled heart devices are prone to failure, resulting in a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning. Both Medtronic and Guidant, manufacturers of heart devices, voluntarily recalled the following models:
Guidant Recall Models
Only the following Guidant models are affected by the FDA recall . All were manufactured between November 25, 1997 and October 26, 2000 :
- PULSAR® MAX Models 1170, 1171, 1270
- PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
- DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
- MERIDIAN® Models 0476, 0976, 1176, 1276
- PULSAR MAX II Models 1180, 1181, 1280
- DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
- CONTAK TR® Model 1241
- VIRTUS PLUS® II* Models 1380, 1480
- INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
- VIRTUS PLUS II and INTELIS II models available only outside the U.S.
Read More on the Guidant Recall
Medtronic Recall Models
In addition to Guidant, the heart device company known as Medtronic has also issued a recall in February of 2005, for specific models implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between April 2001 and December 2003. Devices manufactured during this time period include the following models:
- Model 7230 MarquisT VR
- Model 7274 MarquisT DR
- Model 7232 MaximoT VR
- Model 7278 MaximoT DR
- Model 7277 InSync MarquisT
- Model 7289 InSync II MarquisT
- Model 7279 InSync III MarquisT
- Model 7285 InSync III ProtectT
- LIFEPAK 500 AEDs manufactured in 1997
- 8870 SOFTWARE APPLICATION CARD
VERSION AAA 02
This potential issue does not affect individuals with other models of Medtronic devices or these devices with batteries manufactured after December 2003. If your device is not included in this list, your device is not affected by this situation. If you have one of these recalled heart devices, you may have been notified by Medtronic and receive regular maintenance with your health care provider. In addition to protecting your health, protect your legal rights by contacting a heart device attorney.
Read more on the Medtronic Recall
Guidant Defibrillator & Pacemaker Recall
The United States Food and Drug Administration has determined that the recent safety advisory issued on June 17 by Guidant Corporation is classified as a Guidant pacemaker and defibrillator recall. Two Guidant safety communications were issued to its customer physicians concerning important safety information related to its medical product devices, including defibrillators. The Guidant Recall communication on June 17, related to both the Guidant defibrillator (ICD) and Guidant cardiac resynchronization therapy (CRT) devices. The safety advisory communication on June 24, related to the safety of cardiac resynchronization therapy devices.
Guidant Defibrillator & Pacemaker Products
Guidant is a large manufacturer and distributor of implantable cardioverter defibrillators (ICD) and devices for cardiac resynchronization therapy (CRT). These devices are used to treat abnormalities in heart rate and heart rhythm in patients who have heart disease or heart failure. The devices are designed to be implanted in the chest area and monitor heart function. If an irregularity is detected, then an electrical impulse (shock) or a series of impulses are delivered to various parts of the heart to restart normal function. Guidant Related Deaths
Heart disease continues as one of the biggest killers in the United States . Heart failure, also known as cardiac arrest, occurs when the heart stops pumping blood properly. This illness leads to 200,000 to 400,000 deaths per year. Guidant Defibrillators and Pacemakers
The Guidant devices are designed to extend the lives of heart disease patients, but if a defibrillator is defective, it could have devastating effects, including patient death. When the Guidant devices are defective, either the irregularity of the heart rate is not detected or the proper electrical impulses for treatment are not delivered to the heart. If the proper therapy is not provided, the heart can cease proper functioning and the patient could perish or suffer serious injuries due to lack of proper blood flow. It is Guidant's responsibility to maintain the highest quality standards for their pacemaker and defibrillator products and insure that if any quality issue arises, immediate steps are taken to protect the patients. Two deaths have been reported to date related to the Guidant defibrillator recall defect.
About the Sponsors of this Pacemaker and Defibrillator Information Website
If you or a loved one has been injured due to a defective pacemaker or defibrillator product manufactured by Guidant, you may be entitled to compensation. The sponsors of this website are attorneys who specialize in helping those who have been injured by defective products. Please contact our offices today so that one of our Guidant lawyers may answer any questions that you have and provide a free case review if needed. If warranted, we can file a Guidant lawsuit to help obtain the proper compensation.
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