Medical device maker
warned doctors about possible failures in two lines of pacemakers and initiated a voluntary recall.
The alert was issued following a plant inspection by the Food and Drug Administration.
In a warning letter to doctors, Indianapolis-based Guidant said there could be an "intermittent or permanent loss of pacing output without warning" among its Insignia and Nexus pacemakers. The company said nobody has died from the malfunctions but some patients have been hospitalized.
Guidant said 49,500 pacemakers are at risk of one kind of malfunction that the company believes is the result of foreign material in its timing component, according to Guidant spokesman Dave Knutson.
Among all 341,000 Insignia and Nexus devices distributed worldwide, Guidant says it found 16 that didn't work when tested by doctors before or during implant procedures. The company has not determined a cause for this group of failures.
Guidant had confirmed 36 instances of the first type of malfunction as of early September, including seven pacemakers that weren't working during the implant procedure. Sixteen of the second type of malfunction have been reported.
Among the first group, no failures were observed in devices shipped after March 12, 2004. Based on a statistical analysis, the company expects up to 15 more of the first set of pacemakers to malfunction.
During an inspection of the company's St. Paul, Minn., plant, the FDA noted several instances of noncompliance, including the two trends found in Guidant's Insignia and Nexus pacemakers, according to the company.
Guidant says it gave the FDA a thorough response to its observations and described the steps it has taken and will take to address the problems.
In its letter to doctors, Guidant suggested that they "consider the projected low and declining failure rate" of the devices, and reiterated its initial patient monitoring regimen.
"Guidant recommends verifying pacemaker operation in the packaging prior to the implant procedure" Guidant wrote in its letter to doctors. "Devices exhibiting intermittent or permanent loss of output or telemetry should not be implanted." The company noted that no failures were observed after devices were confirmed to work.
Shares fell 64 cents to $68.85 Thursday morning.