For the third time in recent weeks,
is letting physicians know that
possible problems could arise in some of its heart devices and, as before, the company said the Food and Drug Administration may decide to classify the action as a recall.
The company said Monday that a subset of the following devices made between Nov. 25, 1997, and Oct. 26, 2000, are affected: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.
The pacemakers, which are of an earlier generation design, haven't been sold or implanted for the last four years. Guidant said a hermetic sealing component used in the subset of devices may gradually degrade, resulting in a higher-than-normal moisture content within the pacemaker case late in the device's service life.
As of July 11, Guidant has identified 69 devices that may have exhibited sealing failure from among the 78,000 devices distributed with the component. While no failures have been reported prior to 44 months of service, the likelihood increases with time. Guidant's modeling predicts the rate of failure in the remaining implanted devices to be between 0.17% and 0.51% over the rest of the device's life.
Shares of Guidant were down $1 to $68.41 in early trading.
The company, which is scheduled to report its quarterly earnings Thursday, is in the process of being acquired by
Johnson & Johnson
J&J has had little to say about the past Guidant safety notices, other than it was "engaged in discussions" with Guidant and that it still plans to close the acquisition in the third quarter.
The prior two Guidant warnings had led some to speculate that J&J might try to rework the terms of the deal that values the company at $25.4 billion, or $76 a share.
About 28,000 devices remain implanted worldwide, including 18,000 in the U.S. with an average implant age of 69 months. Guidant said doctors should take into account the needs of individual patients and the specific technical recommendations the company is offering. In addition, Guidant said physicians should consider replacing devices for pacemaker-dependent patients.
Sealing failure could result in serious health complications. Guidant has confirmed 20 reports of loss of pacing output, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope, requiring hospitalization.
Additionally, Guidant has two reports of sustained maximum sensor rate pacing in which heart failure may have developed. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died. The company didn't know if the device experienced the sealing failure because it wasn't returned.
Many of the devices are nearing or have exceeded their estimated longevity and as a result are no longer covered by warranty. Guidant will provide a replacement device at no charge for pacemaker-dependent patients and other patients doctors decide will be best served by a replacement. The company will reimburse patients up to $2,500 for medical expenses remaining after Medicare or health insurance coverage.