Medicine: The Ultimate Recall

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Ever since Consumer Advocate Ralph Nader first forced them to recognize their responsibilities for their products, manufacturers have regularly recalled such items as automobiles and television sets found to be dangerous or defective. Now General Electric has issued what may well be the ultimate recall: 487 heart pacemakers, almost all of them in the chests of patients.

The device is a relatively recent innovation. Most pacemakers, implanted in the chest muscles under the collarbone, send out electric impulses that actually set the heartbeat rate. But G.E.'s $850 standby, or demand, unit is designed to assist hearts that need only intermittent stimulation. It works only when the patient's heart rate slows below normal. After G.E. received word of a malfunction in one unit, it conducted tests which showed that some of the devices were pacing too rapidly. An unwanted increase in the heart rate reduces the time during which blood remains in the cardiac chambers and prevents the chambers from filling completely. The effect is a kind of circulation insufficiency that burdens an already weak heart and could, if uncorrected, bring on a heart attack.

The defect is not in G.E.'s basic design, but in one of the pacemaker's parts. A subcontractor for one of the unit's circuits changed the cement used in its manufacture, unwittingly choosing one that can transmit electric current. This supplies more power from the built-in battery than is needed and affects the governor on the mechanism.

G.E. keeps a list of surgeons who have ordered the unit, and three weeks ago the company began notifying them quietly of the problem. As far as is known, the error has not yet proved damaging to any patient. But it is proving expensive to the manufacturer and inconvenient to some patients. G.E., which has replaced almost all of the devices, is paying for the substitutions. Replacement involves a 15-minute operation and several days of observation in a hospital at a total price of about $1,500 per patient.