Why Post-Market Surveillance Is the Real Test of Medical Device Safety
Effective post-market surveillance depends on HTM teams to bridge the gap between regulatory oversight and real-world performance.
Read More
Search Results for: recall
FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
Read More
Study Finds Defect Risk in Low-Cost Lithium-Ion Batteries
A new report highlights quality control gaps and potential safety hazards from non-OEM 18650 cells, which are used in some medical devices.
Read More
3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
Read More
FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
Read More