Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
Medtronic Octopus Evolution AS Tissue Stabilizer recalled for tubing assembly error
Medtronic identified a manufacturing defect in certain Octopus Evolution AS Tissue Stabilizer units where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite the correct design. This incorrect assembly could affect proper operation during surgical use. The issue affects 288 units distributed worldwide.
- Check the serial number on your device against the affected list (0232670681, 0232709164, 0232709168, 0232709194, 0232709199).
- If your device matches, contact Medtronic or your hospital/surgical center immediately.
- Do not use an affected device until you have confirmed it with Medtronic.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2026More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Octopus Evolution Tissue Stabilizer, Model TS2000
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for potential sterile barrier breach
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