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", ...
FDA tags Medtronic embolisation device recall as Class I
Medtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
Modern Healthcare2h
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.
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 ...
Medtronic slips after FDA notice on product recall (update)
Medtronic (MDT) stock turned lower as the FDA announced a most serious type of recall involving its Pipeline Vantage 027 ...
FDA issues Medtronic embolization device recall and correction notice
In a notice posted to the agency’s website, the FDA noted that on January 30, 2025, Medtronic (MDT) Neurovascular sent all affected customers ...
MedPage Today on MSN6d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
Asia's green jet fuel ambitions exceed demand, heralding exports
Asia's ability to supply sustainable aviation fuel will outpace regional demand this year and next as more production comes ...
MedTech Dive16d
FDA recall notice details J&J pause of Varipulse
Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after ...
The Healthy @Reader's Digest on MSN14d
More Than 900,000 Diabetes Devices Have Been Recalled Nationwide
According to 2021 data from the American Diabetes Association, 2 million Americans have type 1 diabetes—304,000 of which are ...
The BMJ6d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...