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Practice Areas | Guidant
Pacemaker Recall
Guidant, Corp., a manufacturer of medical devices including Implantable Cardioverter Defibrillators ("ICD"s) and Cardiac Resynchronization Therapy defibrillators ("CRT"s), and cardiac pacemakers has recently issued a consumer warnings about numerous models of its pacemaker devices. The warning applies to over 200,000 pacemakers, many of which remain implanted in patients residing in the United States.
On July 22, 2005 the U.S. Food and Drug Administration ("FDA") announced that it had deemed the Guidant Pacemaker problem as a Class I Recall - the most serious type of FDA recall. In a Class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.
On September 26, 2005, Guidant announced the recall of 170,000 of its Insignia and Nexus pacemakers due to various malfunctions with a number of the units. The malfunctions are described as an intermittent or permanent loss of pacing without warning, intermittent or permanent loss of telemetry or appearance of a reset warning message upon interrogation.
On January 21, 2006, Guidant notified physicians that it was expanding the scope of the recall it previously announced to physicians in July, 2005. In its "Dear Doctor" letter, Guidant notified doctors that it was including an additional 54,000 pacemakers in the group of devices that are at risk of "hermetic seal degradation" and therefore at risk for failure.
On June 23, 2006, Guidant announced another recall of certain defibrillators and pacemakers that could be affected by the failure of a low-voltage capacitor. Failure of the capacitor could lead to intermittent or permanent loss of pacing and/or discharging.
The Basis for the Recalls
Guidant issued the July 22, 2005 warning because a sealing component in the pacemaker may deteriorate allowing an unacceptable amount of moisture to accumulate in the device. Such increased moisture can result in a failure of the pacemaker. Such a failure means the device will not provide the vital pacing to the patient's heart or the device will provide too rapid a heartbeat. According to the FDA, "Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possible heart failure and death." As of July 11, 2005, Guidant received reports that 69 of the suspect pacemakers may have failed due to the deterioration of the sealing component. The basis for the expanded recall announced on January 21, 2006 was Guidant's identification of a second group of pacemakers that could be affected by the defective sealing component.
The September 23, 2005 recall was due to malfunctions described as an intermittent or permanent loss of pacing without warning, intermittent or permanent loss of telemetry or appearance of a reset warning message upon interrogation.
The Models Affected
The Guidant pacemakers that are the subject of the warning are:
- 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
- Virtus Plus II Models 1380, 1480
- Intellis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
- Contak TR. Model 1241
- Insignia Models 0482, 0484, 0485, 0882, 0985, 0986, 1190, 1192, 1194, 1195, 1198, 1290, 1291, 1292, 1294, 1295, 1296, 1297, 1298
- Pulsar and Nexus models
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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