FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Modern Healthcare1d
FDA deems Medtronic’s Pipeline Vantage recall ‘most serious’
The recall, which affects two models of Pipeline Vantage embolization devices, is linked to 17 injuries and four deaths.
Healthcare Dive3d
FDA adds hemodialysis devices to shortage list amid B. Braun disruption
The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and ...
STAT7d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Yahoo Finance7d
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period ...
Becker's Hospital Review3d
FDA warns Dexcom over 2 site deficiences
Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego and ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
US FDA says shortage of dialysis device component to extend through early fall
The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in ...
Medtronic recalls embolization devices tied to 17 injuries, 4 deaths
Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions ...
Reuters3d
FDA classifies recall of Medtronic embolization devices as 'most serious'
March 18 (Reuters) - The U.S. Food and Drug Administration on Tuesday classified ... reported injuries associated with the use of devices known as Pipeline Vantage Embolization devices.