Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
Infusion pump companies are perpetuating misconceptions.
The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.
It’s time to address this healthcare problem.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
The device will no longer be available after December 31, 2018.
When ferromagnetic objects enter an MRI suite, they become a serious hazard – here’s how to prevent them from getting in.
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.