bad medical devices blog

Sage Products is recalling limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product because some tested positive for Burkholderia cepacia (B. cepacia).
Subject to the recall are:

product number 9705, lot numbers 10722 and 10729
product number 9706, lot number 10718
product number 9707, lot numbers 10357, 10365, 10641, 10672, 10753, 10755, 10944

Product was distributed […]

Hospitals check medical devices implanted in patients through wireless systems. These systems, Dutch researchers warn, can be corrupted and result in fatal injuries.
In a recent study, these microchip-based “smart” systems failed safety checks but were not implanted in patients. Researchers fear this tendency to fail could result in patient injuries death especially when these devices […]

The Food and Drug Administration announced recently that its own research has determined regulators approved medical devices in 2006 nearly four months faster than it did in 2005.
An FDA study revealed devices before the board were approved, on average, in 438 days in 2005. A year later, that number dropped to 335 days.
A 2002 law […]

Duke University Heath System has reached a confidential settlement on allegations patients in its hospitals were injured after being exposed to a hydraulic fluid found on surgical instruments.
According to The Raleigh (N.C.) News & Observer, an unknown number of patients exposed to this fluid brought this case against Duke.
Several dozen people exposed the fluid have […]

The Food and Drug Administration has warned Chattem, Inc. for not notifying regulators with more information about its dangerous Icy Hot therapy patches.
Reuters reports Chattem released this information in a letter earlier this week. The letter states, the FDA says Chattem did not tell the government it changed its label to help consumers avoid burns […]

In times when Medtronic recalls defective defibrillators already implanted in 268,000 patients, “patients shouldn’t be too eager to try the latest gadgets,” wrote Dr. Richard Deyo, professor of family medicine at Oregon Health and Science University, in a recent Seattle Times Op-Ed. Medtronic has also recalled some implantable infusion pumps, used to send pain medications […]

In case being implanted with recalled defective medical devices isn’t risk enough to take, patients having surgery also take the risk of catheters, scalpels, screws and more being left behind in their bodies after the operation.
Earlier this year, federal Food and Drug Administration officials warned clinicians about the danger of devices that litter patients’ bodies […]

Michael Mastromarino, the mastermind behind the Biomedical body parts scandal, was to get 18 to 54 years in a plea deal, but Justice John Walsh put the sentencing off two weeks after a glitch in a probation report - although he allowed the families to have their say, the NY Daily News reports.
“You are a […]

Health Canada yesterday issued a warning letter to hospital and medical staffers on safety information regarding medical devices coated with contaminated heparin.
Heparin coated medical devices include but are not limited to certain cardiovascular catheters, oxygenators, pumps, filters, blood reservoirs and blood collections tubes. In order to minimize the risk and complications associated with the […]

The Securities and Exchange Commission says it is investigating Wright Medical Group Inc. and a subsidiary over its foreign business practices.
The medical device maker is the latest medical device maker to be probed for its sales overseas.
Though it’s not as if the FDA is too constricting in the U.S. but its reach overseas has […]