Device product
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Z-1473-2026
Product summary
- 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
assembly issue