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Medtronic Perfusion Systems: Octopus Evolution Tissue Stabilizer, Model TS2000

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Perfusion Systems
Product
Octopus Evolution Tissue Stabilizer, Model TS2000
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-05-12
Code info
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Product quantity
134 units
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn Park
State
MN
Country
United States
Event id
98966
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