Octopus 4 Tissue Stabilizer incorrectly assembled tubing positions
Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text does not report any illnesses, injuries, or hospitalizations—the defect is an assembly error identified during manufacturing with no reported adverse consequences, making it a precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly defect identified during manufacturing. The recall affects approximately 590 units distributed worldwide and domestically in the US.
The defect involves incorrect tubing positioning: the short tube was attached to the bottom of the canister and the long tube to the top, contrary to the intended design. This assembly error was identified by Medtronic personnel during the manufacturing process.
Affected units can be identified by UDI-DI 00763000543679 and the following serial numbers: 0231266463, 0231468923, 0231478249, 0231478253, 0231478260, 0231651627, 0231651634, 0231651636, 0231651637, 0231651638, 0231651639, 0231651641, and 0231651642. Users should immediately stop using any affected units and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Octopus 4 Tissue Stabilizer, Model 29400
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 590
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 (1)
- UDI-DI: 00763000543679
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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