FDA recall, , Moderate risk
Octopus 4, Evolution, and Evolution AS Tissue Stabilizer
The Octopus Evolution Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Perfusion Systems, based in Brooklyn Park, Minnesota, recalled the Octopus 4 Tissue Stabilizer, Model 29400, the Octopus Evolution AS Tissue Stabilizer, Model TS2500, and the Octopus Evolution Tissue Stabilizer, Model TS2000, because during manufacturing, 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. The company began the recall on May 12, 2026, and the FDA added it to the Enforcement Report on June 24, 2026, with distribution nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Octopus Evolution AS Tissue Stabilizer, Model TS2500
- UDI-DI
- 00643169668904
- 00613994764379
- 0232670681
- 0232709164
- 0232709168
- 0232709194
- 0232709199
Octopus 4 Tissue Stabilizer, Model 29400
- UDI-DI
- 00763000543679
- 0231266463
- 0231468923
- 0231478249
- 0231478253
- 0231478260
- 0231651627
- 0231651634
- 0231651636
- 0231651637
- 0231651638
- 0231651639
- 0231651641
- 0231651642
Octopus Evolution Tissue Stabilizer, Model TS2000
- UDI-DI
- 00643169668911
- 0232992409
- 0233010063
- 0233010115
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- Medtronic Perfusion SystemsBrooklyn Park, Minnesota
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98966
- Recall numbers
- Z-2575-2026 to Z-2577-2026
All recalls from Medtronic Perfusion Systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
