An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.
The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.
Device establishments must maintain records of acceptable suppliers.
Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.
European scientists have developed a handheld scanner that works similar to a supermarket scanner for early detection of cardiovascular disease.
When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
This offending company has “significant” violations regarding reporting corrections and removals to FDA.
The issue involves problems removing the balloon sheath during cardiac procedures.