FDA DevicesClass II
Octopus Evolution Tissue Stabilizer, Model TS2000
Published: July 1, 2026Recall ID: Z-2575-2026Category: devicesCountry: US
Reason for Recall / Hazard
During the manufacturing process, 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 Evolution Tissue Stabilizer, Model TS2000
Additional Source Details
| Field | Value |
|---|---|
| City | Brooklyn Park |
| State | MN |
| Event id | 98966 |
| Address 1 | 7611 Northland Dr N |
| Address 2 | N/A |
| Code info | UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115 |
| Postal code | 55428-1088 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 134 units |
| Reason for recall | During the manufacturing process, 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 | 20260512 |
| Initial firm notification | Letter |
| Center classification date | 20260624 |
Overview
- Recalling FirmMedtronic Perfusion Systems
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.