Medical Device Safety
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 37 serious injuries as of Aug. 17.
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 incident affecting certain information technology systems that resulted in a network outage and disruption to the company’s operations.”
The American Hospital Association input on the FDA report on the risks and benefits to health and safety that are associated with non-device software as required under Section 3060 of the 21st Century Cures Act.
The American Hospital Association provides comments on the Consumer Product Safety Commission’s agenda and priorities for fiscal years 2027 and 2028.
The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area.
The Food and Drug Administration has identified a Class I recall of North American Rescue first aid kits containing TRUE METRIX Blood Glucose Monitoring Systems by Trividia, which have also been recalled.
The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027.
The Food and Drug Administration has identified a nationwide recall.
The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels.
The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products.