Four patients died and 5 others faced brief scares due to problems involving a backup controller used with Thoratec's HeartMate pumps. The company issued a safety alert to hospitals detailing the issue.
Danish medical device maker Coloplast is said to have paid $16 million to settle lawsuits claiming it injured women with vaginal-mesh inserts. With settlement talk swirling around at least 5 more makers of the plagued devices, that has some watchers saying the time may be ripe for a global settlement.
Medtronic has revealed details about the mounting legal troubles it faces concerning its Infuse bone growth spinal implant. About 700 lawsuits involving 1,000 personal injury cases are now pending over the controversial product, according to a recent regulatory filing.
All of the Big Three devicemakers have worked to get their pacemakers certified compatible with MRI scans, but it doesn't look like they'll need to undertake similar efforts to ensure their patients will be safe in a CT scan.
Pennsylvania's Endo Health Solutions is building up a $520 million stash to cover expected fallout from ongoing lawsuits alleging its vaginal mesh implant products have harmed patients.
In the last 15 months, HeartSine Technologies has continued to deal with a Class I global recall of its Samaritan defibrillators, after 5 patients died due to possible device malfunctions. But the FDA slapped the Irish company with a new letter warning that its post-recall actions have generally fallen short.
Global fallout from the Poly Implant Prothèse breast implant scandal continues, as the Welsh government refused to pay £1.2 million to replace faulty implants in women.
A Teleflex subsidiary is voluntarily recalling one of its tracheal tubes because of reports that it can kink during use and cut off a patient's air supply. The FDA slapped its Class I recall designation on the Pennsylvania company's action, meaning the defect carries with it a risk of major injury or death.
It's a story that could confirm the worst fears of med tech implant wearers at the highest level of U.S. government: Some time during the first half of 2013, hackers reportedly broke into the computer networks of the big three medical device makers, and the breach might have stayed open for "several months."
Medtronic has failed to prevent another lawsuit involving its Infuse bone growth spinal implant from advancing. It's an ominous sign as the Minnesota device giant gears up for a growing number of related cases that are working their way through the court system.