FDA DeviceClass IINotable

FDA Recall: Octopus 4 Tissue Stabilizer, Model 29400

Date: 2026-07-01
Brand: Medtronic Perfusion Systems
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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

590 units

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