Deep Brain Stimulation Devices Charging Problems
Errors In Deep Brain Stimulation Devices Result To Failures. Medtronic Deep Brain Stimulation Devices Chargers Malfunctioning. Medtronic has warned that some of its Model 37751 rechargers for its deep brain stimulation devices may be malfunctioning. In an "Urgent Field Safety Notice" addressed to healthcare professionals this … [Read more...] about Deep Brain Stimulation Devices Charging Problems
Heater-Cooler Devices Heart Surgery Infections Risk
Contaminated Heater-cooler Devices Creates More Troubles. Contaminated Heater-Cooler Devices Linked To A Serious Infections. Contaminated heater-cooler devices manufactured by LivaNova, formerly known as Sorin Group S.p.A., have been linked to serious infections in patients undergoing open heart surgery since 2012. During surgery, … [Read more...] about Heater-Cooler Devices Heart Surgery Infections Risk
Regulatory Loophole Can Allow Unsafe Devices Onto Market
Data from the U.S. Food and Drug Administration (FDA) shows that there are over 100,000 medical devices on the market. Unfortunately, not all of them are safe. In fact, agency data indicates that between 13 and 75 devices are recalled in the United States every day. Motley Fool reports that a regulatory loophole, which allows devices … [Read more...] about Regulatory Loophole Can Allow Unsafe Devices Onto Market
Caution With New Leadless Defibrillator Devices
Cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. A leading and outspoken cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. According to a Reuters report this week, Dr. Robert Hauser writes in the most recent edition of Journal of the … [Read more...] about Caution With New Leadless Defibrillator Devices
Transvaginal Mesh Products May Face Tougher Scrutiny
The U.S. Food & Drug Administration (FDA) is considering a proposal to revoke 510(k) approvals for transvaginal mesh devices. If the agency follows through, makers of transvaginal mesh devices currently on the market might have to submit new data to the agency in order to keep them there. Transvaginal mesh products are used … [Read more...] about Transvaginal Mesh Products May Face Tougher Scrutiny
J&J Warned Over Marketing of Two Devices
Illegally marketing two products. In the newest string of debacles surrounding drug giant Johnson & Johnson (J&J), it just received a warning letter from the U.S. Food and Drug Administration (FDA) stating it is illegally marketing two products, wrote Daily Finance. We’ve previously written that J&J is expecting more … [Read more...] about J&J Warned Over Marketing of Two Devices
St. Jude 6 French Engage Introducer Devices Class I Recall
French Engage Introducer Devices. St. Jude Medical has issued an urgent recall for 6 French Engage Introducer devices. The US Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious recall action. The Engage Introducer is used to implant catheters and electrodes into blood vessels during surgery and … [Read more...] about St. Jude 6 French Engage Introducer Devices Class I Recall
Recall Issued for Becton Dickinson IV Devices
Recalled by Becton Dickinson & Co. for a potentially lethal defect. Millions of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems have been recalled by Becton Dickinson & Co. for a potentially lethal defect.The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD … [Read more...] about Recall Issued for Becton Dickinson IV Devices
Hospira Recalls Devices Over Defective Power Cords
Hospira Equipment Defective Power Cords. Hospira Inc. is issuing an urgent recall for some medical delivery equipment because the devices include defective AC power cords manufactured by Electri-Cord Manufacturing Corporation.</p. According to UPI, the items included in this recall include several LifeCare and Plum … [Read more...] about Hospira Recalls Devices Over Defective Power Cords
Older Medical Devices To Get Safety Reviews
U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. According to a statement from the Food & Drug Administration (FDA), all of the medical devices slated for review were … [Read more...] about Older Medical Devices To Get Safety Reviews
Cell Phone – Cancer Link Seen in Study
Another Cell Phone Study has Linked Use of the Devices to Cancer. Another cell phone study has linked use of the devices to cancer. According to a Tel Aviv University study, prolonged use of cellular phones is linked to cancer and people who use cell phones for lengthy periods of time every day are 50 percent more likely to develop … [Read more...] about Cell Phone – Cancer Link Seen in Study
Ban Unproven ‘Energy Medicine’ Devices
Unproven Energy Medicine Devices Have Injured Many People in America. Unproven medical devices have injured many people in the United States, yet the Food & Drug Administration (FDA) has not moved aggressively to protect consumers from these unsafe – and often illegal – devices. Now, officials from the state of Washington have … [Read more...] about Ban Unproven ‘Energy Medicine’ Devices
Study questions reliability of public defibrillators
Automated external defibrillators were recalled because of the potential for malfunction. A review of safety data raises questions about the reliability of the heart zappers that hang on the walls of airports, shopping malls and health clubs. Harvard Medical School researchers found that over the past decade, one in five automated … [Read more...] about Study questions reliability of public defibrillators
Boston Scientific Battery Problem in Some Devices
Boston Scientific admits some implantable cardiac devices have battery problems. Boston Scientific Corp on Monday said it had notified doctors that some of its implantable cardiac devices, which it acquired as part of its purchase of Guidant Corp. last month, could be at risk for early battery depletion. Boston Scientific, whose … [Read more...] about Boston Scientific Battery Problem in Some Devices
FDA Warns of Cochlear Implant Risks
Cochlear implant face an increased risk of bacterial meningitis. Children with an early version of the cochlear implant face an increased risk of bacterial meningitis beyond just the first two years following implantation of the hearing devices, the Food and Drug Administration warned Monday. The increased risk means the young … [Read more...] about FDA Warns of Cochlear Implant Risks
Study: Pacemakers Can Cause Heart Failure
People with the most common pacemaker types are more likely than similar people without pacemakers to die from or be hospitalized for gradual heart failure, sometimes within six months, according to a large study confirming doctors' belief the life-saving devices actually harm some patients. Experts say the tens of thousands of … [Read more...] about Study: Pacemakers Can Cause Heart Failure
Americans Ignorant of Their Implants
25 million Americans are living with implanted medical devices, from pacemakers to artificial joints. Up to 25 million Americans are living with implanted medical devices, from pacemakers to artificial joints, but too many patients have unrealistic expectations of how long implants will last and don't even know what model is in their … [Read more...] about Americans Ignorant of Their Implants
