Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
What this means
Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.
- Check your device serial number against the affected list: 0232992409, 0233010063, 0233010115
- Contact Medtronic if you have an affected unit for instructions on replacement or return
- Do not use the device if you believe it is affected
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-2575-2026More Medtronic recalls
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