Boston Scientific recalls pacemakers

Boston Scientific Corp. recalled nearly 50,000 pacemakers and other heart-rhythm devices yesterday, and chief executive Jim Tobin said he expects to find more problems as the company takes a closer look at the products it acquired from the troubled former Guidant Corp.

``I know as sure as I'm sitting here that we will have further recalls," Tobin said during a conference call with Wall Street analysts yesterday.

``I also know everyone in the industry will have further recalls. That's just the kind of industry we're in."

Investors reacted sharply to the news. Shares of Boston Scientific's stock fell $1.20, or 6.6 percent, to $17.06 -- its lowest level since 2002. Since it completed the Guidant acquisition this year, the company's stock has declined more than 20 percent.

The Natick medical-device maker said it found an electrical problem in the devices that can cause them to malfunction. It sent a letter to doctors Friday telling them to check patients whose devices came from batches with potential problems.

Among the 27,200 recalled devices that have already been implanted in patients, five malfunctions have been reported so far. None were fatal, the company said.

Prior to the merger with Boston Scientific, Guidant recalled more than 200,000 defibrillators and pacemakers for potential malfunctions that could lead to the devices' failing to deliver their lifesaving electric impulses to the heart.

Although Boston Scientific's management has steadily portrayed Guidant's problems as rooted in communication, saying Guidant executives should have been more forthcoming with the heart doctors who install their devices, Tobin said yesterday that, ``In truth, there are deeper issues than that."

In this case, Boston Scientific said, some batches of pacemakers and defibrillators were made with a faulty capacitor, a small component that is supposed to hold an electrical charge. Capacitor failure can cause the device to stop working.

The company's letter to doctors indicates that it is too early to predict how often the current devices would fail. The pacemakers and defibrillators are part of a large family of increasingly sophisticated implantable electronic devices that can not only keep hearts beating steadily, but can sense a potentially fatal rhythm and deliver a sudden electrical kick to restart the heart.

Boston Scientific bested Johnson & Johnson in a bidding war for Guidant on the belief that heart-rhythm devices, already a multibillion-dollar worldwide market, would continue to grow to the end of the decade and beyond.

Since paying $27 billion for Guidant, Boston Scientific has been hit with repeated trouble related to the Indiana company's devices, including patient lawsuits and federal warnings about quality control.

The latest recall affects Insignia and Nexus pacemakers; Contak Renewal TR/TR2 cardiac-resynchronization pacemakers; and Ventak Prizm 2, Vitality, and Vitality 2 implantable cardioverter-defibrillators. Patients who have the devices should be checked by a doctor, but the devices do not necessarily need to be removed.

Stephen Heuser can be reached at sheuser@globe.com.