Medical Device Network on MSN8d
FDA tags Medtronic embolisation device recall as Class I
The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as ...
Modern Healthcare2d
FDA warns Dexcom over continuous glucose monitor testing
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Becker's Hospital Review13d
3 medical device recalls and corrections
Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: ...
Business Insider9d
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 an Urgent Medical Device Recall letter warning user ...
MassDevice9d
Medtronic recalls embolization device after reported deaths
The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the ...
Seeking Alpha9d
Medtronic slips after FDA notice on product recall (update)
According to the FDA, the company has issued an urgent medical device recall, notifying all affected users of the recall on Jan. 30. The recall followed reports of the device's tube section ...
MedTech Dive9h
Dexcom rejects claims of unauthorized device changes in FDA warning letter
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
MassDevice6d
Smiths Medical has a serious recall involving vein access ports
The FDA has labeled Smiths Medical's recall of ProPort Implantable Plastic Port as Class I, the most serious kind.
MedTech Dive9d
Top device firms report safety data late: BMJ
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...
Medtronic recalls aneurysm-treating device linked to four deaths
The FDA recall affects more than 25,000 of the Fridley-run company’s devices and follows reports of 17 injuries.
health.economictimes.indiatimes8d
FDA classifies recall of Medtronic embolization devices as 'most serious'
Bengaluru: The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", following reports of the deaths of four patients.
Yahoo Finance6d
FDA tags Becton, Dickinson and Company infusion software recall as Class I
The US Food and Drug Administration (FDA) has tagged the recall of software used ... by software failure modes while Smiths Medical issued a medical device correction for its software-affected ...