The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...
The Food and Drug Administration Feb. 18 announced that ICU Medical is voluntarily recalling certain lots of its potassium ...
The Class I recall warned that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment or removal. This interaction could result in ...
The number of recalls stayed high in 2024 but fewer units of products got recalled. There were 3,232 product recalls in 2024, ...
Abiomed has issued an Urgent Medical Device Correction updating the instructions for its Impella RP with SmartAssist and also its Impella RP Flex with SmartAssist heart pumps. The US Food and Drug ...
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