FDAHealthMay 12, 2026
Medtronic Perfusion Systems — Octopus Evolution Tissue Stabilizer, Model TS2000
⚠️ 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 Tissue Stabilizer, Model TS2000
- Lot code
- UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Additional details
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 134 units.
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