Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
What this means
During manufacturing, Medtronic discovered that tubing was installed backwards on some Octopus 4 Tissue Stabilizer devices: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This affects 590 units with specific serial numbers distributed nationwide.
- Check the serial number on your device against the list provided in the full recall notice.
- Contact Medtronic immediately if you have an affected unit for instructions on replacement or return.
- Do not use the device if you suspect it may be 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-2577-2026More Medtronic recalls
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