Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
What this means
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.
The agency's original wording
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 recalls
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