Medtronic Recalls Octopus Nuvo Tissue Stabilizers Due to Assembly Error
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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 this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Florida and Indiana. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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.
Original source: FDA Official Notice ↗
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