Hacking Risk Sparks 465,000 St. Jude Pacemakers Recall
Patients vulnerable to a software glitch The U.S. Food and Drug Administration (FDA) is warning that over 465,000 patients who had St. Jude pacemakers implanted may be vulnerable to a software glitch that could permit hackers to remotely disable their batteries or make the devices to run at deadly speeds. According to the FDA recall … [Read more...]
St. Jude Defibrillators May Be Linked To Serious Cardiac Side Effects
Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who were implanted with potentially defective St. Jude defibrillators and leads that may cause serious side effects, including cardiac tamponade. The defective medical device lawyers at Parker Waichman are also investigating possible fraying defects … [Read more...]
St. Jude Medical ICD and CRT-D Defibrillators Recall
St. Jude Medical Implantable Cardioverter Defibrillators Subject of Recall Following Deaths. Jude Medical Inc. recently announced a recall of about 40 implanted heart devices over risks of premature battery depletion. The defect has been associated with two deaths. The U.S. Food and Drug Administration (FDA) has deemed the recall a … [Read more...]
After Fixing Battery Defect, St. Jude Continued to Sell Older Pacemakers
St. Jude Medical is facing criticism regarding certain models of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These heart devices deliver electrical shocks or pacing in patients. Recently, certain models of the Fortify, Unify and Assura ICD and CRT-D were recalled … [Read more...]
Investigation of St. Jude Medical Devices Now Includes FDA
The U.S. Food and Drug Administration (FDA) has now joined the investigation into security claims that devices made by St. Jude Medical can be hacked remotely. These claims are still being defended by St. Jude. Muddy Waters Capital, an investment group, says that St. Jude Medical pacemakers and defibrillators are particularly … [Read more...]
St. Jude Medical Recalls Defibrillator Leads Due to Damaged Insulation
On January 22, 2016, device maker St. Jude Medical announced that a voluntary global field safety action related for the company's Optisure Dual Coil Defibrillation Leads has now been designated a Class 1 advisory by the Food and Drug Administration (FDA). Damaged leads may lead to an electrical malfunction wherein the defibrillator … [Read more...]
St. Jude Medical’s Riata Lead Externalization Linked to Electrical Failures
Riata Lead externalization is a problem where the lead wires of the device pokes through the insulation. The findings of a Danish study suggest that “lead externalizations” with St. Jude Medical’s recalled Riata and Riata ST defibrillator leads are associated with electrical failures and gets worse over time. Lead externalization is … [Read more...]
St. Jude Medical’s reputation in the balance amid Riata, Durata scandals
St. Jude Medical Riata And Durata Scandals. What is the name of the medical device blacked out in a recent federal report made public by St. Jude Medical, one of the leading companies in the industry. Speculation abounds, according to a New York Times report, on which product is redacted from a recent federal report on the medical … [Read more...]
Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products
Surgical Ablation Products Sold Illegally. Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in … [Read more...]
St. Jude Medical Inc. Warns Radiation Affect its Older Generation ICDs
St. Jude Medical Inc. ICDs Injury Lawsuits. In a physician's advisory dated October 6, 2005, St. Jude Medical Inc. announced that it has discovered that background levels of atmospheric ionizing cosmic radiation, more commonly known as cosmic rays, can affect a limited number of its older generation implantable … [Read more...]
US Pacemaker Manufacturer Faces British Lawsuit
St Jude Medical, a major manufacturer of heart valves and pacemakers, is to face a lawsuit in Britain. St Jude Medical, a major manufacturer of heart valves and pacemakers, is to face a lawsuit in Britain over its Silzone heart valves, which were discontinued after a recall in January 2000. The Minnesota based company, which is … [Read more...]
Husband Sues Over Wife’s Death
British man has begun legal proceedings against the American manufacturers of a heart valve. A British man has begun legal proceedings against the American manufacturers of a heart valve he claims contributed to the death of his wife. Myrtle McCombe, 44, of Cookstown, Northern Ireland, died on 3 July 1998, two months after she … [Read more...]
Pacing Defibrillators May Carry More Risks
Pacing Defibrillators Risks. Sophisticated defibrillators may knock the heart out of rhythm, increasing the risk of hospitalization and death, according to a new study. The costly models include a pacemaker that helps maintain a normal heart rhythm by delivering electrical impulses to both the heart's upper and lower … [Read more...]
St. Jude Medical Lawsuit Will Soon Face Critical Juncture
Lawsuit Filed In Court Against St. Jude Medical. A battle to turn 37 individual product liability lawsuits filed in federal court against Little Canada-based St. Jude Medical Inc. into a class-action suit will head to court this fall. It will be a crucial step for the 2-year-old case, which likely won't conclude for another … [Read more...]
