Class 1 Recall: Guidant Corp. Pacemakers

Date Recall
Initiated:

July 18, 2005

Product:

The following models of Guidant pacemakers, 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

Use:

Pacemakers of this type are surgically implanted in persons with a heart disease affecting the heart’s ability to generate and conduct electrical impulses. These devices generate small electrical impulses that trigger the heartbeat.

Recalling Firm:

Guidant Corporation – CPI Division

4100 Hamline Ave. N.
Saint Paul , Minnesota 55112-5700

Reason for Recall:

A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

Public Contact:

Consumers with questions may contact Guidant Corporation at 1-866-GUIDANT (1-866-484-3268).

FDA District:

Minneapolis

Advice to Users:

• If you believe you are pacemaker dependent, contact your physician soon to discuss your treatment options.
• Continue your normal doctor appointments.
• If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.
• If you are not sure which model you have, or if you have other questions regarding your device, consult with your physician.
• If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

For additional information on this product recall, see the Guidant Corporation Web site at: http://www.guidant.com/news/500/web_release/nr_000558.shtml, which includes a copy of the company’s notice sent to physicians (http://www.guidant.com/physician_communications/PDM.pdf), and the FDA press release located at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01210.html