FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medtronic Octopus Nuvo Tissue Stabilizer recalled for incorrect tube assembly
What this means
Medtronic found a manufacturing error in 2 units of the Octopus Nuvo Tissue Stabilizer where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite of the correct design. This could affect how the device functions during use.
- If you have lot number 0232837110, stop using the device immediately
- Contact Medtronic or your distributor for a replacement or instructions
The agency's original wording
Hazard
During the manufacturing, 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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL and IN.
Affected count
2 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2026More Medtronic recalls
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
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