The new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators. All of the recalled defibrillators were manufactured by Guidant, which was bought by Boston Scientific in April 2006 for $27 billion.
Other problems with Guidant heart devices resulted in a large recall in June 2005, from which the company faces thousands of complaints and lawsuits.
List of New Recalls
Recalled Guidant devices include:
• Contak Renewal 3 HE CRT-Ds (Models H177 and H179)
• Contak Renewal 3 CRT-Ds (Models H170 and H175)
• Vitality 2DR ICDs (T165)
• Vitality 2 VR ICDs (T175)
• Vitality AVT ICDs (A155)
• Vitality DS DR ICDs (T125)
• Vitality EL DR ICDs (T135)
The Problem: Accelerated Battery Depletion
Faulty capacitors have been causing accelerated battery depletion and reducing the time between their elective replacement indicators and end of defibrillator life to less than three months.
The average implantable defibrillator lasts five to seven years.
Although there have been no reports of serious injuries or deaths, the company has confirmed 19 incidents of battery depletion. Boston Scientific sent a Product Advisory Letter to patients and sent doctors and clinics detailed information about risks.
FDA Warned Guidant in 2005
Back in 2005, the Indianapolis Star reported that the FDA had sent a stern letter to Guidant about Guidant's quality control issues at its main manufacturing plant. In the letter, the FDA stated that the company could not export certain pacemakers and defibrillators from the St. Paul plant until the problems were corrected.
More than 100,000 Guidant heart rhythm devices were recalled between 2005 and 2006.
It has also come to light that in June of 2003, Endo Vascular Technologies (EVT), a subsidiary of Guidant, pleaded guilty to 10 felony counts and agreed to pay $92.4 million in civil and criminal penalties related to its Ancure Endograft system, a stent-graft device. EVT admitted that it had lied to the government and hidden thousands of malfunctions with the Ancure Endograft, including 12 patient deaths.
Justice Department Inquiry
The U.S. Justice Department and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues related to several of its defibrillators, which have been recalled.
The inquiry reflects allegations by medical and legal professionals that Guidant withheld pertinent information about defibrillator malfunctions and mechanical design defects.
If You Have a Guidant Defibrillator
Guidant defibrillator patients are advised to seek the advice of their physicians if they have not yet done so. In addition, patients and their families are advised to watch for signs of defect, which could include:
• Electrical shocks from the defibrillator
• An audible beep
• Loss of consciousness
• Rapid heart rate
Heart failure, stroke and even death are possible side effects of a faulty defibrillator.