Medtronic, Inc.
Medtronic, Inc.: 3 recalls listed since January 2026 across FDA.
By year
- 20263
By agency
- FDA3
By category
- Medical Device3
All recalls (3)
Medtronic OmniaSecure Model 3930M Leads
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation.
Medtronic Sphere-9 Catheter
The Sphere-9 Catheter can cause ventricular fibrillation during RF therapy in patients with certain Biotronik defibrillators.
Medtronic Abre Venous Self-Expanding Stent System
The Abre Venous Self-Expanding Stent System may have a Nitinol anomaly causing reduced stent diameter and radial force, potentially leading to migration.



