Medtronic Octopus Nuvo Recall - Tubing Assembly Issue

FDA: Device Recalls Class II

Filed March 4th, 2026

Detected March 29th, 2026

Summary

The FDA has issued a Class II recall for Medtronic Octopus Nuvo Tissue Stabilizer systems due to a manufacturing defect where tubing was incorrectly positioned. This recall impacts nationwide distribution in Florida and Indiana.

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What changed

The FDA has initiated a Class II recall for the Medtronic Octopus Nuvo Tissue Stabilizer system (Product Number TSMICS1) due to a manufacturing assembly issue. During production, Medtronic personnel identified that the short and long tubes were attached to the canister in the incorrect positions, contrary to the intended design. This defect poses a risk that could lead to adverse health consequences.

Healthcare providers and distributors in Florida and Indiana who have received this product should immediately cease use and follow Medtronic's instructions for returning the affected devices. Compliance officers should ensure their organizations have procedures in place to identify and quarantine recalled medical devices and report any adverse events associated with this product to the FDA.

What to do next

Cease use of affected Medtronic Octopus Nuvo Tissue Stabilizer systems
Follow Medtronic's return instructions for recalled devices
Report any adverse events to the FDA

Source document (simplified)

Medtronic Perfusion Systems

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1473-2026 · 20260304 · Ongoing

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.