ONLINE RESOURCES
FDA LINKS
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U.S. Food and Drug
Administration (FDA)
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health ... -
FDA Updates Consumers on Guidant Corporation’s Implantable
Defibrillators
To help patients and doctors take appropriate action pertaining to the health risks of certain defibrillators from Guidant, the FDA has classified the devices into three categories, with class 1 being the most serious, based on the probability that the device failure could lead to adverse health effects ... -
Guidant Initiates Worldwide Physician Communications Regarding
Important Safety Information and Corrective Action about
Implantable Cardiac Defibrillators
The FDA advices physicians to discontinue implants of certain defective Defibrillators after Guidant Corporation voluntarily alerts physicians about important safety information regarding certain devices ... -
FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM®
2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
The FDA offers new information and recommendations on steps to take concerning malfunctions occurring with Guidant’s PRIZM® 2 and CONTAK RENEWAL® implantable cardioverter defibrillator (ICD) devices ...
HEALTH & CONSUMER INFORMATION
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U.S. Consumer
Product Safety Commision
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction ... -
Recalls.gov
Too provide better service in alerting the American people to unsafe, hazardous or defective products, six federal agencies with vastly different jurisdictions have joined together to create www.recalls.gov -- a "one stop shop" for U.S. Government recalls ... -
ConsumerReports.org
Empowering consumers with information to allow for a fair, just, and safe marketplace ...
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Guidant Says 28,000 Pacemakers May Need Replacement
Guidant Corp. say doctors should consider replacing cardiac pacemakers implanted in the chests of 28,000 people worldwide ... -
Defibrillator industry accelerating the pace of change
Due to continuing pressure and demand by patients, doctors and the FDA, Guidant and other defibrillator companies are increasingly releasing more information sooner about the possible defects of the devices ... -
Guidant Issues Warning on 28,000 Pacemakers
Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide ... -
Defibrillator recall sends patients scrambling
Nervous patients called their doctors Monday to have potentially faulty implanted heart devices checked out after the company offered to replace thousands of them because of flaws ... -
FDA Gives Highest Warning About Certain Guidant Defibrillators
The government says a malfunction in some of the Guidant Corporation defibrillators recalled recently could cause serious injury or death ... -
Guidant defibrillators recalled
A series of failures in Guidant Corp. defibrillators that resulted in two deaths prompted the company to issue warnings to doctors ... -
FDA halts expansion of network to monitor medical device safety
North Reading medical technology consulting firm, said data from more hospitals might have led to earlier detection of problems with Guidant's defibrillators ... -
Lawsuit claims faulty implanted defibrillator caused death
The lawsuit, filed Wednesday in Duval Circuit Court, claims Guidant, of Indianapolis, was aware of problems with its defibrillators for about three years, but ... -
FDA: Some Guidant Defibrillators Recalled
The FDA says Guidant Corp. is recalling certain implantable defibrillators and cardiac resynchronization defibrillators ... -
New worry for heart patients as Guidant defibrillators are ...
The latest Guidant safety announcement affects the Contak Renewal 3 model, Contak ... At least 74,900 defibrillators worldwide are now under a safety warning, with ...
LEGAL LINKS
