Octopus Evolution AS Tissue Stabilizer, Model TS2500
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.
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Medtronic Perfusion Systems
- Affected product
- Worldwide - US Nationwide distribution.
- Risk or reason
- 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.
- Remedy or action
- UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
- Official ID
- Z-2576-2026