Medtronic Recalls Octopus Nuvo Tissue Stabilizers Due to Assembly Error
Medtronic Perfusion Systems has initiated a voluntary recall of specific Octopus Nuvo Tissue Stabilizer units due to a manufacturing defect involving incorrectly positioned tubing.
What Happened
Medtronic Perfusion Systems has initiated a voluntary recall of the Octopus Nuvo Tissue Stabilizer after identifying a manufacturing assembly error. During an internal review, personnel discovered that the tubing on the device was incorrectly positioned: the short tube was attached to the bottom of the canister and the long tube was attached to the top. This configuration is contrary to the product’s intended design.
Which Products Are Affected
The recall involves the Octopus Nuvo Tissue Stabilizer, a disposable tissue stabilization system. Only a limited number of units are affected by this specific manufacturing issue.
- Product Name: Octopus Nuvo Tissue Stabilizer
- Product Number: TSMICS1
- Recall Number: Z-1473-2026
- UDI-DI: 00763000543693
- Lot Number: 0232837110
- Quantity: 2 units
- Distribution: Affected units were distributed in the states of Florida (FL) and Indiana (IN).
What You Should Do
Medtronic Perfusion Systems notified affected customers via a formal letter initiated on January 13, 2026. Healthcare providers and facilities should check their inventory for the specific lot number (0232837110) and follow the instructions provided in the firm’s notification letter regarding the return or replacement of the defective units.
Why This Matters
This Class II recall highlights a deviation from the device’s intended design. Proper assembly of medical devices is critical to ensure they function as expected during surgical procedures and to maintain patient safety standards.
Source
Information provided by the FDA.
Source: FDA Official Notice