Guidant Revisits Safety Advice

The company says a prior recommendation can actually increase patient risk.
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Guidant

(GDT)

, which has disclosed a trio of product problems in recent weeks, said Friday that an earlier recommendation meant to ensure the safety of a group of its heart devices can actually increase the risk of patients running into trouble.

The company is sending the new information to doctors who have patients with the affected devices. The devices are the Ventak Prizm AVT, the Vitality AVT and the Contak Renewal AVT defibrillators. The Food and Drug Administration may consider the action a recall, Guidant said.

In June, the company sent a letter to physicians saying that the atrial therapy subgroups of certain ICD and CRT-D products can lock up and interfere with patient therapy. At the time, two events had been confirmed out of about 20,950 devices that have been implanted. As a result, one of Guidant's recommendations was to make a programming change to the device.

On July 11, a third event was reported despite the recommended programming change. The third event, similar to the first two, resulted in no apparent injury to the patient.

However, based on a study of the latest problem, Guidant learned that one of its original suggested fixes can cause a "significantly higher probability of occurrence of latching for certain devices." Therefore the company changed its programming recommendation and told doctors about the new approach they should take.

Guidant, which is being acquired by

Johnson & Johnson

(JNJ) - Get Report

, has had three recent announcements in which it said problems may arise in some of its heart devices. On Thursday, the company said its second-quarter revenue rose 4% from a year ago, but net income fell, partly as a result of costs for product recalls. Guidant recorded a pretax charge of $113 million, or 26 cents a share after tax, for the recalls.

Shares of Guidant were down 30 cents to $69.33. J&J is buying the Indianapolis-based company for $25.4 billion, or $76 a share.