Z-1473-2026 Class II Ongoing

Recalled by Medtronic Perfusion Systems — Brooklyn Park, MN

Recall Details

Product Type
Devices
Report Date
March 4, 2026
Initiation Date
January 13, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
939 units

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.

Distribution Pattern

US Nationwide. Global Distribution.

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