Medtronic Perfusion Systems is recalling two units of the Octopus Nuvo Tissue Stabilizer (Product Number TSMICS1), a disposable medical device used during surgical procedures. The company identified a manufacturing defect where the internal tubing was attached to the wrong parts of the canister, with the short tube at the bottom and the long tube at the top. This incorrect assembly contradicts the intended design and could interfere with the device's proper function during surgery. Because these units are used in clinical settings, Medtronic is coordinating directly with affected facilities in Florida and Indiana to manage the return or replacement of the devices.
The incorrectly positioned tubing could cause the stabilization system to malfunction during a surgical procedure, potentially leading to surgical delays or complications. While only two units are affected, the assembly error represents a failure to meet design specifications necessary for patient safety.
Quantity: 2 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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