On June 17, 2005, Guidant Corporation issued a defibrillator recall for cardiac defibrillators implanted in 50,000 patients around the world due to potentially fatal malfunctions of the devices. There are approximately 38,000 patients in the United States with Guidant brand defibrillators, which reports indicate have failed 45 times and are responsible for at least two deaths since May 30th.
The Guidant recall was issued for the following models of cardiac defibrillators and pacemakers:
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Prizm 2 DR model 1861
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Contak Renewal model H135
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Contak Renewal 2 model H155
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Ventak Prizm AVT
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Vitality AVT
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Renewal 3 AVT
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Renewal 4 AVT ICD's
- 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.
The Guidant Defibrillator Recall
Critical wiring errors in Guidant defibrillators may cause a short circuit which can overload their delicate wiring. Prizm AVT, Vitality AVT and Renewal AVT can be serviced at a doctor’s office to reduce this risk, but Prizm 2 DR and Contak Renewal must be replaced in order to eliminate potential hazards. Those at the greatest risk should immediately consult their doctors and continue to have checkups every three months to ensure that the devices are still working properly.
The Food and Drug Administration released a statement stating that they did not require Guidant to recall its products, but that they nevertheless supported the decision to address such serious allegations. The fact that this issue was finally addressed is of small comfort to the 50,000 people who continue to live in constant fear that their life-saving medical equipment may fail them when they need it the most.
Guidant Corp knew that there were problems in its Prizm 2 DR model and continued to market it, but demanded a total redesign of the unit. The company knew the model had failed a small number of times before 2002, but claimed that future revisions would make it safer. Doctors then discovered that Contak Renewal defibrillators built before August 26th, 2004 demonstrated a large risk of shorting out and failing to function properly. Only when presented with two such problems did Guidant act in the best interest of the public and offer to recall and service their defective products.
If you or your loved one uses Guidant brand defibrillators, it is possible that you may experience problems with the device. If you have concerns about the recall consult with your doctor and then contact the Guidant defibrillator recall lawyers of Ennis & Ennis, P.A. for a free legal consultation. |