A welding defect may allow moisture to enter affected heart pumps, which can lead to device failure, the US FDA explained. Medtronic first announced the recall in April.
A recall of Medtronic’s Heartware Ventricular Assist Device (HVAD) pump implant kit has been slapped with high-risk class I status by the US Food and Drug Administration, the agency announced on 8 June.
The system, which helps the heart continue to pump blood, is used both as a bridge to cardiac transplant for...
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
