The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15. 

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The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic…
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The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and…
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Boston Scientific, a large supplier of medical devices, said in an Aug. 26 statement posted on its website that on Aug. 25 it “identified a cybersecurity…
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The Food and Drug Administration has issued early alerts for the following products: •    Certain epidural kits by Medical Action…
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The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine…
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The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline…