Tag Page MedicalDevices

FDA Calls Out ICU Medical Over Pump Fixes

ICU Medical just got a major FDA warning for tweaking their infusion pumps without getting the green light first. Turns out, they made changes to fix some serious issues—like false alarms and therapy interruptions—but skipped the required paperwork. The FDA says those updates could impact patient safety, and ICU Medical’s own rules say they should’ve filed for clearance. This isn’t the first time a med device company’s been caught skipping steps, either. Wild how often this happens! #MedicalDevices #FDA #HealthcareNews #PatientSafety #InfusionPumps #Health