Guidant Corp. issued recalls or safety advisories for almost 170,000 of its top-selling pacemakers on Thursday following a two-week federal inspection of its cardiac unit.
Since June, Indianapolis-based Guidant has recalled or issued warnings about 88,000 heart defibrillators — including its leading seller, the Contak Renewal 3 — and almost 200,000 pacemakers because of reported malfunctions. Pacemakers use mild electrical current to speed a slow heartbeat; defibrillators use a bigger jolt to correct life-threatening irregular heartbeats. Surgery to remove and replace the devices is risky.
The latest advisory is the fifth in three months by the nation’s second-largest cardiac-device maker and has renewed questions over its reporting of potential problems and a planned $25.4 billion acquisition by New Jersey-based Johnson & Johnson. Some 80 percent of Guidant’s heart products are now under recall or an advisory, according to an estimate by Jan Wald, an analyst with A.G. Edwards & Sons.
“It’s gotten so that we keep waiting for the other shoe to drop,” said Dr. Douglas Zipes, a heart expert at the Indiana University School of Medicine.
Johnson & Johnson stands by its August statement that it continues to work with Guidant on the impact of the recall announcements, spokesman Jeffrey Leebaw said. The company expects a decision on the merger by the Federal Trade Commission in October.
Insignia and Nexus lines
Guidant’s announcement Thursday, which focused on its top-selling Insignia and Nexus lines, affects about 56 percent of the company’s pacemakers. The company urged patients to consult with their doctor but did not say the devices should be removed.
Failures in the devices has led to nine cases of emergency hospitalization, but no deaths, Guidant said.
A Food and Drug Administration report found that failures with the Insignia line were first reported in 2003 and occurred as recently as July. As of September, users had not been informed of the potential for failure and the company continued to distribute the product, the report said.
Guidant said that, as of Sept. 6, it had confirmed loss of pacing output in 36 of 49,500 Insignia and Nexus pacemakers, including seven that were detected by doctors before being implanted. The failures affected devices shipped before March 2004, before a supplier made changes in a timing component, Guidant said.
The company reported telemetry failures in 16 of 341,000 of the pacemakers as well.
Fred McCoy, president of Guidant’s Cardiac Rhythm Management division, said the failures were reported in annual filings to the FDA. But he said the issue of when to disclose problems in products is a vexing one.
“One of the problems that any company that deals in high-tech medical technology is dealing with the low likelihood of failure,” McCoy said. “The decision about when to communicate actively is something we all struggle with.”
Guidant under fire for delays
Guidant has been under fire for waiting years to warn patients about a problem in its Prizm 2 DR defibrillator. Industry officials gathered in Washington last week to discuss standards for notifying the public about issues with the implanted devices, and at least one lawmaker has called for more investigation of Guidant’s problems.
“Companies should not be allowed to hide problems until the FDA comes to seek them out,” said Rep. Edward J. Markey, D-Mass. “It is not the prerogative of the company to decide whether the defect warrants action — that decision should be left in the hands of the patient with the help of well-informed physicians.”
Guidant also said Thursday that it had notified doctors that the failure rate for two defibrillators — the Contak Renewal and Contak Renewal 2 — was nearly triple what it had earlier estimated. The company said the devices, which were recalled June 17, had been associated with three deaths, an increase from one death reported earlier.
Guidant projected a failure rate for the defibrillators of 0.7 percent to 1.8 percent.
Despite the problems, Zipes said pacemakers and defibrillators have provided much-needed treatment to patients with heart problems.
“There’s no question that the benefits outweigh the risk,” he said.
Guidant spokesman Dave Knutson said the FDA inspection ended Sept. 1 at Guidant’s Cardiac Rhythm Management facilities in St. Paul, Minn.
The FDA classified Thursday’s recall as Class II, meaning that any injury caused by a malfunction should be temporary or pose a slight threat of a serious nature.
Shares of Guidant rose 86 cents to close at $70.35 in trading on the New York Stock Exchange. Shares of Johnson & Johnson fell 2 cents to close at $64.68.