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The truth is, a recall notice is rarely the end of the story. Instead, it marks the beginning of a longer, more personal ...
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 ...
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 ...
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Urgent Medical Device Recall Issued for VentilatorBaxter 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 ...
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Medtronic slips after FDA notice on product recall (update)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 ...
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 ...
The Hospital Authority says it is proactively following up with medical device supplier Abbott Laboratories about the product ...
The recall was initiated because the ... Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment ...
On Friday, the FDA classified a recall ... Inari Medical updated the use instructions for the ClotTriever XL catheter after discovering serious adverse events caused by the device becoming ...
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