Recall Z-1473-2026— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2026-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1. Reason: 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..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-13
- Firm location
- Brooklyn Park, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.