July 2005
Medical devices recalled
Guidant defibrillators and pacemakers affected
In June 2005, two deaths and dozens of product failures led to recalls of cardiac debrillators implanted in the chest of patients susceptible to dangerous arrhythmias, or abnormal heart rhythms.
On July 18, 2005, Guidant announced the recall of nearly 30,000 pacemakers that could stop working during the late stages of their life cycle. On July 22, the Food and Drug Administration classified Guidant's recall as Class I, the most serious kind. As many as 69 pacemakers may have failed according to Guidant. All the reported failures occurred in devices that had been implanted in patients for at least 44 months. The pacemakers are expected to last an average of 69 months.
The problems involve an older design that's no longer made; in fact, the suspect units haven't been sold for four years. The risk of failure exists because a hermetic sealing material could degrade prematurely and allow moisture to accumulate inside the pacemaker. The recall includes the following models, made from Nov. 25, 1997, to Oct. 26, 2000:
Guidant defibrillators and pacemakers affected
In June 2005, two deaths and dozens of product failures led to recalls of cardiac debrillators implanted in the chest of patients susceptible to dangerous arrhythmias, or abnormal heart rhythms.
On July 18, 2005, Guidant announced the recall of nearly 30,000 pacemakers that could stop working during the late stages of their life cycle. On July 22, the Food and Drug Administration classified Guidant's recall as Class I, the most serious kind. As many as 69 pacemakers may have failed according to Guidant. All the reported failures occurred in devices that had been implanted in patients for at least 44 months. The pacemakers are expected to last an average of 69 months.
The problems involve an older design that's no longer made; in fact, the suspect units haven't been sold for four years. The risk of failure exists because a hermetic sealing material could degrade prematurely and allow moisture to accumulate inside the pacemaker. The recall includes the following models, made from Nov. 25, 1997, to Oct. 26, 2000:
- Pulsar models 0470, 0870, 0970, 0972, 1172, and 1272;
- Pulsar Max models 1170, 1171, and 1270;
- Pulsar Max II models 1180, 1181, and 1280;
- Discovery models 1174, 1175, 1273, 1274, and 1275
- Discovery II models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, and 1286;
- Meridian models 0476, 0976, 1176, and 1276;
- Virtus Plus II models 1380 and 1480;
- Contak TR model 1241; and
- Intelis II models 1483, 1484, 1485, 1384, 1385, 1349, and 1499.
Of the 78,000 affected pacemakers originally distributed worldwide, about 28,000 remain in use (18,000 in the U.S.), according to Guidant. The company says the likelihood of failure is small, but the risk increases the longer the pacemaker remains in use.
If you have one of the pacemakers, contact your doctor to discuss a course of action, including the pros and cons of surgical replacement. Guidant recommends that doctors consider replacement for completely pacemaker-dependent patients. Pacemaker failure could cause sudden faintness, loss of consciousness, and death. The leakage problem could also cause a sustained rapid heart rate, which might be fatal. If you experience shortness of breath, dizziness, lightheadedness, a prolonged fast heart rate, or loss of consciousness, contact your doctor immediately or go to an emergency room.
Even though many of the devices are no longer under warranty, Guidant will provide a free replacement pacemaker, if necessary, and reimburse patients up to $2,500 for out-of-pocket medical expenses. The free replacement program will be in effect through Dec. 31, 2005.
If you are unsure which pacemaker model you have, check with your doctor. If you know the model and serial number and want to find out if it is part of the recall, go to www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 866-484-3268.
