FDA-Device2026-07-01Class IIPROCESSING DEFECT

Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly

OTHERNationwide distributiondevice

Medtronic Octopus Evolution Tissue Stabilizer recalled for assembly error

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
Hazard

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.

Who it affects
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
134 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Octopus Evolution Tissue Stabilizer, Model TS2000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2575-2026

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