← FDA ENFORCEMENT
Z-2575-2026Class II

Medtronic Perfusion Systems

Recalling firm
Medtronic Perfusion Systems
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
Worldwide - US Nationwide distribution.
Firm state
MN
Product quantity
134 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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.

Product description

Octopus Evolution Tissue Stabilizer, Model TS2000

Code / lot info

UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.