The U.S. Food and Drug Administration reserves its Class I status for the most serious, life-threatening medical device problems. For comparison, between 2017 and 2020, Medtronic averaged about ...

A comprehensive analysis from a recent study on trends and impacts related to US FDA medical device recalls has been made available for review. The research, focused on Class I and Class II ...

Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The ...

Medtronic has logged yet another Class I medical device recall, the FDA’s most serious type, after reports of injuries with its HawkOne system for clearing out clogged arteries. The recall ...

The U.S. Food and Drug Administration has issued a Class I recall ... reported deaths in connection with the device’s defect. The recall, which the medical device manufacturing company initially ...

J&J’s Abiomed previously notified healthcare providers of the risks with an urgent medical ... a Class I label March 20, the agency’s most serious recall designation—however, no device ...

The first step is to thoroughly document all potential hazards and conditions that could arise during the use of the medical device ... the Instructions for Use (IFU) or directly in the meter's ...