Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1473-2026

January 13, 2026

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 98354
Status
Ongoing
Classification
Class II
Quantity
939 units
Official record key
device-enforcement:Z-1473-2026

Official wording

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.

Code information: UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly issue