February 14th, 2008 joshua
Canadian patients awaiting hip replacement surgeries are being forced to wait because of a recall from Stryker Orthopedics Cork, Ireland plant.
Stryker recalled the Trident hemispherical and Trident PSL Shells in late January. Canada is now importing the parts from Stryker’s Mahwah, N.J., facility. We recently reported on this blog that the FDA sent Stryker two […]
February 11th, 2008 joshua
Patients with Implanted Cardioverter Defibrillators already face numerous complications from their life-saving device, but news from the U.S. Food and Drug Administration gives reason for more concern.
The USDA posted a recent article from journal Nursing2008 that tells of a man dying after receiving an elective surgery. The reason was linked to his ICD not being […]
February 8th, 2008 joshua
At least a dozen women are suing Mentor Corp. over complications regarding its ObTape, a sling that aims to stop incontinence, or a leaking bladder.
One woman in a KING-TV report says her device worked well at first – as she took part in a Virginia Mason clinical trial. But after just five months, the woman […]
February 7th, 2008 joshua
A recent article in Journal of General Internal Medicine says medical devices need more rigorous review in the United States, the medical news site DotMed News reports.
The study, conducted by the University of California at San Francisco says the time following Food & Drug Administration (FDA) approval of a medical device is most important. This […]
February 5th, 2008 joshua
A Medtronic drug pump manufactured in the 20th Century is at the focus of a Food and Drug Administration (FDA) “class 1” recall.
The FDA advisory is the most serious the agency issues. The SynchroMed El pumps are supposed to deliver drugs to a specific region of the body, but these older pumps’ motors are stalling. […]
February 4th, 2008 joshua
Despite speculation about the effectiveness of drug coated stents, the Food and Drug Administration approved the sale of another.
The Medtronic “Endeavor” stent is the first medical device of its kind to be approved in the United States since 2006, when drug-coated stents were linked to an increased risk of heart attacks.
Medtronic says it will ship […]
February 1st, 2008 joshua
A pair of Texas men have sued Medtronic, Medtronic Puerto Rico and Medtronic Puerto Rico Operations Company over implantable heart defibrillators they say have cost them the enjoyment of life.
Both men were implanted with an ICD that features the Sprint Fidelis 6948 lead wire system, currently subject to voluntary recall by Medtronic, The Southeast Texas […]
