FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medtronic Octopus Nuvo Tissue Stabilizer recalled for incorrect tube assembly

OTHERNationwide distribution

Check Medtronic Octopus Nuvo Tissue Stabilizer lot 0232837110

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
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.

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-1473-2026

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