In a healthcare landscape increasingly shaped by technology, two names that stand out for their innovation and long-term ...

Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures.

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.

On Jan. 30, 2025, Medtronic sent an urgent medical device recall letter recommending that customers do not use and return all unused 027 devices. They should read the updated instructions before ...

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. Medical Device Recalls by the Numbers Highlights from ...

A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device design (31.4%), process control (16.1%), or component design or ...

In 2023, the FDA updated its guidance on identifying predicate devices, urging device makers to consider any reported safety issues or recalls. Some devices continue to be used even after being ...

ICU Medical subsidiary Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. There have been 35 reported injuries. There have been two reports of death.