Official recall notice
FDA DeviceClass IINotable
FDA Recall: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Recall date
- 2026-03-04
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Recommended action
What to do
2 units
Product description
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.