Octopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall. The source text identifies a manufacturing assembly defect but does not report any illnesses, injuries, hospitalizations, or deaths, making this a precautionary recall based on the tubing positioning error.
Plain-English summary
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000 (UDI-DI: 00643169668911) due to an assembly defect identified during manufacturing. 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.
The recalled devices were distributed worldwide with US nationwide distribution. Affected serial numbers are 0232992409, 0233010063, and 0233010115.
Healthcare providers who have received this product should contact Medtronic Perfusion Systems for instructions regarding the product. Patients or healthcare facilities with questions should consult with their healthcare provider or the manufacturer.
The recalled product
- Product
- Octopus Evolution Tissue Stabilizer, Model TS2000
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- assembly-defect
- tubing-malposition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00643169668911
- Serial Numbers: 0232992409 0233010063 0233010115
Distribution
Distributed nationwide across the United States.
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