FDAHealthMay 12, 2026
Medtronic Perfusion Systems — Octopus Evolution AS Tissue Stabilizer, Model TS2500
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 12, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- Octopus Evolution AS Tissue Stabilizer, Model TS2500
- Lot code
- UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
Additional details
UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 288 units.
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