Device Safety

Latest Headlines

Latest Headlines

FDA warns of 9 deaths due to coatings on minimally invasive intravascular medical devices

The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.

FDA flags underactive thyroid cases in babies receiving iodine-containing contrast agents

The FDA is alerting the public that rare cases of underactive thyroid were reported in babies who were given iodine-containing contrast agents for X-rays and other medical imaging procedures.

Registry data shows more than 10% of TAVR patients are being treated off-label

Registry data shows that more than 10% of TAVR recipients are being treated off-label, meaning they do not meet the FDA's recommended criteria for use.

Crime syndicates are hacking devices to steal private medical information for profit

By installing replicas of medical devices at more than 60 hospitals, cybersecurity firm TrapX Security has demonstrated the presence of shadowy groups who are hacking devices to steal valuable personal medical information and sell it on the black market, Bloomberg reports.

FDA issues Class 1 recall for Hamilton Medical ventilators

Ongoing issues that have dogged Hamilton Medical ventilators have triggered a second Class 1 recall of the devices this year. This time the Swiss-based company is recalling 1,126 of the machines from U.S. healthcare providers.

Sientra slides amid implant manufacturing fallout in Brazil

Last month, breast implant company Sientra fell by more than 50% after its sole manufacturer, Silimed, had its CE mark suspended by the U.K. Department of Health. Now the company is dealing with the aftermath, with Brazilian regulators shutting down Silimed's factory in the country and sending Sientra's shares spiraling downward as a result.

BMJ: Bayer's Essure calls for more follow-up surgeries than traditional sterilization

Bayer is facing more bad news for its contraceptive implant Essure, as a new study shows that women outfitted with the company's device are more likely to need follow-up surgeries compared to individuals who undergo a traditional sterilization procedure.

HeartWare shares plunge on news of stalled pump trial

HeartWare was down about 30% after announcing that it might not be able to resume a European trial of its MVAD implantable heart pump next month, a month after the company put the study on hold due to manufacturing and software issues with the device.

FTC warns consumers against buying unapproved weight-loss devices

Alongside the FDA, the Federal Trade Commission oversees the marketing and promotion of medical devices. FTC Consumer Education Specialist Aditi Jhaveri took to the agency's blog to warn consumers against purchasing unregulated devices that promote "do-it-yourself" projects, such as weight loss.

NEJM study finds tentative link between TAVR leaflet mobility and incidence of stroke

The unexpected and unwelcome detection of reduced leaflet mobility in transaortic valve replacements is back in the spotlight thanks to a study of the phenomenon in the New England Journal of Medicine. The paper reveals some tantalizing clues about the technical issue, but it remains mysterious, and the FDA is maintaining its stance that "bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications."