FDA DevicesClass II
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product ...
Published: March 4, 2026Recall ID: Z-1473-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Additional Source Details
| Field | Value |
|---|---|
| City | Brooklyn Park |
| State | MN |
| Event id | 98354 |
| Address 1 | 7611 Northland Dr N |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 55428-1088 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 939 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260113 |
| Initial firm notification | Letter |
| Center classification date | 20260226 |
Overview
- Recalling FirmMedtronic Perfusion Systems
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide. Global Distribution.