FDAHealthMay 12, 2026
Medtronic Perfusion Systems — Octopus 4 Tissue Stabilizer, Model 29400
⚠️ 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 4 Tissue Stabilizer, Model 29400
- Lot code
- UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
Additional details
UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 590 units.
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