Three more deaths are linked to faulty Guidant defibrillatorsDec 15, 2005 | AP
Three more patients with recalled defibrillators manufactured by Guidant Corp. have died, bringing the total number of known deaths linked to the faulty products to seven, officials with the troubled medical device maker said.
The additional deaths were reported to federal regulators in August, September and November, according to reports Guidant filed with the Food and Drug Administration.
One patient died July 28. It was not immediately clear when the other patients died.
All three had defibrillators with damaged or faulty wiring, according to the federal reports.
Overall, five patients with faulty Contak Renewal or Contak Renewal 2 defibrillators have died, as well as two patients with the Ventak Prizm 2 defibrillator, Guidant spokeswoman Annette Ruzicka said Wednesday.
Guidant said in a statement that it continually collects and analyzes information about the performance of its products.
Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators including its top 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.
The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls. FDA spokeswoman Julie Zawisza declined to comment on the reports.