Octopus Evolution AS Tissue Stabilizer recall (Medtronic Perfusion Systems)
Medical deviceClass IIOngoing
Summary: Medtronic Perfusion Systems is recalling Octopus Evolution AS Tissue Stabilizer, Model TS2500. Reason: 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.
What is being recalled
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2576-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 12, 2026 |
| Reported | July 1, 2026 |
| Company | Medtronic Perfusion Systems |
| Company location | Brooklyn Park, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 288 units |
More recalls from Medtronic Perfusion Systems · all medical device recalls · recalls from May 2026