FDA recall Z-1473-2026

Medtronic Perfusion Systems · Class II · device

Product

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Reason for recall

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.

Distribution

US Nationwide distribution in the states of FL and IN.

Key facts

Status
Ongoing
Initiation date
2026-01-13
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2026