Boston Scientific Recalls Devices

Boston Scientific Corp. on Monday recalled nearly 23,000 heart pacemakers and defibrillators that could fail because of an electrical flaw, and the company asked doctors to check 27,000 patients who had been implanted with potentially faulty devices.

The announcement marked the second time Boston Scientific has warned about products of the former Guidant Corp. since the Natick, Mass.-based company bought Guidant in April for $27 billion.

Shares of Boston Scientific fell $1.20, or nearly 7%, to $17.06, their lowest level in nearly four years.

Executives reiterated earlier warnings that they expected additional recalls involving Guidant heart devices.

They said Guidant-related troubles were no worse than they had expected when they launched a successful bidding war against Johnson & Johnson in December to acquire Guidant’s business in the $10-billion market for devices to restore normal heart rhythm.

Jim Tobin, Boston Scientific’s chief executive, said it could take as long as two years to fix design, manufacturing and supplier problems that contributed to a wave of recalls and warnings last year involving nearly 300,000 devices.

The problems involve far more than Guidant’s shortcomings in promptly notifying doctors, patients and regulators about device flaws, Tobin said.

“In truth, there are deeper issues that will require time to address, that will lead to problems that will then have to be communicated,” Tobin told analysts during a conference call.

“It will take 18 months to two years to get all of those things taken care of,” Tobin said.

The latest recall involved certain batches of a low-voltage capacitor provided by an outside supplier. Tobin said quality control reviews should have detected the problem. Instead, five malfunctions were reported in devices that either had already been or were about to be implanted in patients.

“That should never happen, and it happened batch after batch after batch, and now we’re paying the price,” Tobin said.

No deaths were linked to the five malfunctions, but in two cases pacemaker patients temporarily lost consciousness. In four cases, patients required surgery to replace devices.