FDA DeviceClass IINotable

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

Date: 2026-03-04
Brand: Medtronic Perfusion Systems
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

2 units

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