Official recall notice
FDA DeviceClass IINotable
FDA Recall: Octopus Evolution Tissue Stabilizer, Model TS2000
- Recall date
- 2026-07-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
During the manufacturing process, 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.
Product description
During the manufacturing process, 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.
Affected products
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115