Octopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.
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 recall involving a manufacturing assembly defect with no reported illnesses or injuries documented in the source text. The hazard is a design/assembly error that could affect device function, but represents a moderate risk that warrants correction rather than a high-severity threat.
Plain-English summary
Medtronic Perfusion Systems is recalling the Octopus Evolution AS Tissue Stabilizer, Model TS2500, due to an assembly issue identified during manufacturing. In the affected units, the short tube was incorrectly attached to the bottom of the canister and the long tube to the top, contrary to the intended design.
A total of 288 units have been distributed nationwide in the United States and worldwide. The affected serial numbers are 0232670681, 0232709164, 0232709168, 0232709194, and 0232709199. The UDI-DI numbers are 00643169668904 and 00613994764379.
Healthcare facilities and users who have received this product should cease use and contact Medtronic to arrange return or replacement of affected units. The incorrect tubing configuration may impact proper device function during surgical procedures.
The recalled product
- Product
- Octopus Evolution AS Tissue Stabilizer, Model TS2500
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- assembly-defect
- tubing-misalignment
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: 00643169668904
- 00613994764379
Distribution
Distributed nationwide across the United States.
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