Guidant Corp. and FDA Recently Announced the Recall of Thousands of Pacemakers Manufactured between November 25, 1997 and October 26, 2000 Because of Leak Caused by Defective Seal
Parker & Waichman, LLP (www.yourlawyer.com) announces that it has commenced an investigation into defective pacemakers manufactured by Guidant Corporation (NYSE:GDT). The investigation comes after Guidant voluntarily recalled thousands of pacemakers because of a leak caused by a defective seal that can result in serious injury or death to the patient. Parker & Waichman, LLP is offering free case evaluations to all cardiac defibrillator patients, as many patients do not know their exact defibrillator model. To receive a free case evaluation, please visit: /practice/overview.htm?topic=Guidant%20Pacemakers .
The FDA issued a press release earlier today announcing a Class I recall of the Guidant pacemakers. A Class I recall is the most serious recall that the FDA can issue and indicates a strong likelihood that the defective product can cause serious injury or death. All of the recalled pacemakers were manufactured between November 25, 1997 and October 26, 2000. Guidant has said that 78,000 of these pacemakers were originally distributed and that approximately 18,000 devices remain implanted in patients in the United States today. The company also warned that the likelihood of injury or death increases with time since implant and urged patients to visit their physicians as soon as possible.
The defective pacemaker models are listed below:
— PULSAR(r) MAX Models 1170, 1171, 1270
— PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
— DISCOVERY(r) Models 1174, 1175, 1273, 1274, 1275
— MERIDIAN(r) 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(r) Model 1241
— VIRTUS PLUS(r) II* Models 1380, 1480
— INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
The failure of the pacemaker to provide pacing output can cause sudden faintness or loss of consciousness and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death. As of July 11, 2005, Guidant had received sixty-nine reports of pacemakers that may have failed because of the leakage. Twenty of these pacemakers were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate; one patient was admitted to the hospital and later died. Unfortunately, there is no way to test if a pacemaker is defective or not, and the removal and replacement of a device can carry serious health risks.
Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-YOURLAWYER (1-800-968-7529).
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