In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac ... "Abbott is not removing product from commercial distribution." Rather, Abbott revised instructions for use ...

Medical device companies typically will recall a product voluntarily, but the FDA may issue a mandatory recall if a company refuses to do it and the product poses a major health risk. A recall is ...

Product recalls are a major headache for pharma, but device manufacturers can feel the pain, too. In the U.S., the FDA's 510(k) process for approval is under intense scrutiny 1, with critics ...

Shares of Medtronic (NYSE:MDT) reached a session low on Tuesday after the U.S. Food and Drug Administration (FDA) announced a product recall ... an urgent medical device recall, notifying all ...

Baxter International Inc. issued an urgent medical device recall for Life2000 ... that have this issue. The recall applies to Life2000 ventilators with the product code MS01-0118 that have the ...

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical ... recall of 1,617 units of its 072 Aspiration System (also known under the pr ...

Inari Medical updated the use instructions ... The use of the affected product may cause serious adverse health consequences, including device entrapment, vessel damage, and/or blockage of lung ...

Over 16,000 units were affected by this recall, according to the U.S. Consumer ... People with an external medical device or weakened immune systems could develop a "serious infection" if they ...