bad medical devices blog

More and more research indicates hip resurfacing surgery, used an alternative to total hip replacement for middle-aged women, often leads to more failures and the need for a follow-up surgery.
Hip resurfacing surgery aims to preserve more of the femoral bone than the traditional total hip replacement.
Resurfacing has been used in Europe and Australia longer than […]

A cardiologist at Beth Israel Deaconess Medical Center told the American Heart Association conference on Sunday that headphones and earbuds (popular with MP3 players and iPods) can alter the performance of implanted heart devices.
These devices include implanted defibrillators as well as pacemakers and can fail to operate if headphones are kept too close to the […]

The Food and Drug Administration recently announced it is notifying health care professionals and patients that Tyco Healthcare Group is recalling one lot of ReliOn insulin syringes due to a possible mislabeling.
The syringes are the sterile, single-use, disposable, hypodermic syringes with permanently affixed needles. The label error could lead to patients to administer a dose […]

Medtronic has released updated figures on its defective Sprint Fidelis defibrillator leads, recalled in October of last year for fracturing/malfunctioning and killing several people, injuring hundreds of others.
WebMD reports Medtronic yesterday released updated data showing that the leads, have had 42-month failure rates of 6.3% based on SLS figures and 3.8% according to the CareLink […]

The FDA has announced yet another Class 1 recall of a medical device claiming to cure cancer and other diseases and conditions. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices.
The recalled medical device is called Vibrational Integrated Bio-photonic Energizer (VIBE) Machine […]

Kickback payments from medical device makers to orthopedic physicians in exchange for the promotion and use of a specific hip or knee replacement have begun again.
In Sept. 2007, the medical device industry was forced to stop these payments and several thousand doctors across the U.S. actually stopped receiving these bonus payments they received in exchange […]

After five deaths, the Thoratec Corporation has issued a worldwide recall of its Heartmate II Pumps. The implant, which is used as a temporary solution for patients waiting for heart transplants, has the potential to malfunction and kill those implanted with it.
The FDA’s recall notice states that wear and fatigue of the percutaneous lead […]

The FDA on October 20 sent a letter to healthcare practitioners warning about complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences.
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh […]

University of Minnesota Medical School is considering a new conflict-of-interest policy so strict that doctors wouldn’t even be able to accept Post-it Notes bearing a drug company’s logo, the Star Tribune reports. The far-reaching policy, which if enacted would be among the toughest in the nation, comes as congressional investigators and the U.S. Justice Department […]

A year after the big Medtronic defibrillator recall, only a few defective wires that connect defibrillators to hearts have been replaced, the Toledo Blade reports some Toledo cardiologists say.
Last October, Medtronic recalled its Sprint Fidelis lead, the wire connecting the implanted defibrillators to the heart, after four reports of death due to fracturing lead […]