Medical Device Safety Recalls and Alerts Continue

New Class I recall for Boston Scientific Infinion CX Leads (lead fracture risk, 1079 units). FDA advisory on unregistered medical device. Ongoing recalls: Omnipod 5, Medline kits, BD devices, Dräger, Resmed, Abiomed, and others. New case report on Impella 5.5 thrombosis presenting as hyperbilirubinemia – diagnostic trap. Systemic failure in injury reporting highlighted. New: FDA early alert on Impella introducer leakage. New: PA-PSRS study on inpatient CGM use documents safety events from off-label use.