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.
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.
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 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.
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.
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.
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.
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.
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.
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.