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- FDA issues early alert on Abiomed Impella controller safety issueThe FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
- Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary WarehouseThe U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…