FDAsafety guidance83% confidence
Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Sandoz.
Regulatory Analysis
Certain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
Supporting Context
- Therapeutic area
- Cardiovascular · Anticoagulant
- Sub-indication
- General
Related signal: Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets