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Defective Medical Devices

After 2 deaths, defective internal pacemakers being recalled

St. Jude Medical Inc, one of the giants of the medical device industry, has announced that it is recalling some of its internal pacemakers after a defect in the devices’ batteries came to light. Though St. Jude claims the risk of serious harm to patients is low, at least two users of the devices have died so far. The devices affected by the recall are called ICDs and CRT-Ds. Both are implanted in the chests of people dealing with heart failure or arrhythmias, and are designed to shock the heart when it is racing dangerously high in order to return…

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Class I recall issued for diabetes monitoring devices

A leading manufacturer of glucose monitoring devices has issued a Class I recall of two of its devices. Dexcom is recalling its G4 Platinum and G5 Mobile Continuous Monitoring Systems (CGM) due to a potentially deadly defect with their alarms. The devices are supposed to sound an audible alarm if the user’s blood glucose has reached a dangerous level. However, Dexcom and the U.S. Food and Drug Administration have discovered that the alarms on the G4 and G5 CGMs tend not to make a sound when they are supposed to. Under the FDA’s guidelines, a Class I recall involves a…

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Medical scope recalled after hundreds infected

After hundreds of patients suffered infections in just three years, Olympus Corp. has announced that it is recalling its medical scopes. The recall comes after Olympus had notice of the fact so-called quote superbug” infections were being found in plaintiffs who underwent an endoscopy with the company’s scopes, but the company delay taking the scopes off the market while it waited for FDA approval of a new scope design so the effect of on the company’s bottom line would be minimized. The San Francisco Chronicle recently reported on this recall. The duodenoscope being recalled is used to identify and treat…

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FBI probing Johnson & Johnson’s reaction to surgical tool defect

The possibility of a cover-up of a surgical tool that many accuse of spreading cancer in women has drawn the attention of the FBI. Investigators have reportedly begun interviewing witnesses to examine the possibility that several parties, including medical device makers like Johnson & Johnson, failed to report the defect to authorities. The device in question is called a morcellator. It uses spinning blades to cut tissue into small pieces, so that the surgeon can remove it through small slits cut into the skin. Some women who underwent the procedure had undetected cancer in their uterus. The morcellator sprayed hidden…

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2 die in California hospital from devices infected with superbug

Medical devices and tools must be sterile, or else expose patients to serious infection. Hospitals and medical clinics are often full of germs, because those facilities are where sick people go. If doctors, nurses and device manufacturers are not sufficiently careful, disease can spread from patient to patient. Two people who died at a California hospital recently may have been infected with the CRE “superbug” by a contaminated endoscope. Doctors use endoscopes to look inside their patients’ body cavity or organ, using a light attached to the device’s end. Officials at Ronald Reagan UCLA Medical Center say the patients both…

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Study: information about medical device safety sorely lacking

Consumer product safety is important regardless of the type of product; any item can be dangerous if it enters the stream of commerce with hazardous defects. But when it comes to products that are going to be implanted directly into or onto the human body, it is blatantly obvious that safety standards need to clear a higher bar; dangerous or defective medical devices can have dramatic health impacts. For this reason, there are requirements in the law that manufacturers of moderate- to high-risk medical devices that have received U.S. Food and Drug Administration approval provide publically available scientific evidence verifying…

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Woman wins suit, warns others about hazards of medical device

After a patient was implanted with a synthetic mesh sling designed to cure minor urinary incontinence, she began to feel sharp, tearing pain. She alleged that the serrated edges of the synthetic mesh sling were acting like miniature saw blades in her pelvis. The woman filed suit against the maker of the mesh device, Boston Scientific. At trial, her lawyers presented internal documents from Boston Scientific showing that even after the product was being marketed, the company’s own researchers recommended “longer follow-up.” Rather than take this advice, Boston Scientific circulated an internal memo cautioning employees against sharing the recommendation with…

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FDA considers possibility of standardizing medical device labels

Sometimes an inherently dangerous product is perfectly safe if used as directed. There could be a variety of sources of information about using a product safely, but one of the most common is product packaging and labeling. For example, picture a sleep aid medication. Take too much, and it could be harmful. But labels on the packaging tell consumers how much to take and when to take it in order to avoid harmful side effects. Consumers know they will find this information on the packaging when they purchase a sleep aid, and they know how to quickly find it because…

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My Medtronic insulin pump has been recalled; Now what?

Medtronic recently issued a recall of various insulin pump models due to a faulty design that allows users to accidentally deliver the maximum amount of insulin by inadvertently pressing a button. This recall concerns an enormous amount of devices: nearly 560,000 insulin pumps have been recalled. A total of 444,374 of these devices are in use in the United States. If you are suffering from diabetes, or if you have a loved one who has diabetes, you could be relying on one of these dangerously designed insulin pumps. So if you have heard about the recall, what are your next…

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Medtronic recalls MiniMed insulin pumps due to hypoglycemia risk

Delivery of the proper amount of insulin at the right time is critical for anyone suffering from diabetes. Individuals living with diabetes must depend on medical supply companies to provide the products they need to maintain a healthy blood sugar level. But what happens when something goes wrong? In March of this year, the Medtronic Corporation distributed a letter warning users of several MiniMed insulin pump models that accidentally pressing buttons on one of the devices could cause it to administer the maximum amount of insulin. The letter said that users should check to confirm the correct dose was flashing…

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