FDA DeviceClass IINotable
FDA Recall: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
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
Related Recalls
2026-05-27 · FDA_DEVICE
FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary
Medtronic Perfusion Systems
2026-05-27 · FDA_DEVICE
FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary
Medtronic Perfusion Systems
2026-05-27 · FDA_DEVICE
FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonar
Medtronic Perfusion Systems
2026-05-27 · FDA_DEVICE
FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmo
Medtronic Perfusion Systems