FDA-Device2026-03-04Class II
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medtronic Perfusion Systems
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.
Sold states
US Nationwide distribution in the states of FL and IN.
Affected count
2 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2026Original summary
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 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. UDI-DI: 00763000543693; Lot Number: 0232837110 Distribution: US Nationwide distribution in the states of FL and IN. Affected quantity: 2 units
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