The FDA recall affects more than 25,000 of the Fridley-run company’s devices and follows reports of 17 injuries.

The FDA has labeled Smiths Medical's recall of ProPort Implantable Plastic Port as Class I, the most serious kind.

The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the ...

The recall impacts the Pipeline Vantage devices compatible only with 0.027" inner diameter microcatheters, Medtronic said.

Medtronic's recall of embolization device has been classified most serious by the U.S. Food and Drug Administration (USFDA), ...

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions ...

The FDA announced that Medtronic initiated a device recall and correction for embolization devices. The FDA has identified ...

Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most serious type of recall. There were 1,048 medical device recalls in 2024 ...

In a notice posted to the agency’s website, the FDA noted that on January 30, 2025, Medtronic (MDT) Neurovascular sent all affected customers ...

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: ...

XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...