FDA DevicesClass II
Octopus 4 Tissue Stabilizer, Model 29400
Published: July 1, 2026Recall ID: Z-2577-2026Category: 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 4 Tissue Stabilizer, Model 29400
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: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642 |
| Postal code | 55428-1088 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 590 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.