Medtronic Octopus Nuvo Tissue Stabilizer recalled for incorrect tube assembly
Medtronic found a manufacturing error in 2 units of the Octopus Nuvo Tissue Stabilizer where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite of the correct design. This could affect how the device functions during use.
From the FDA notice · Read the official notice ↗ · All Medtronic recalls
What to do
- If you have lot number 0232837110, stop using the device immediately
- Contact Medtronic or your distributor for a replacement or instructions
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 2 units
- Illnesses reported
- None reported
- Manufactured in
- 7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
- Classification
- Class II
- Recall number
- Z-1473-2026
In the FDA's words
- Description
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. UDI-DI: 00763000543693; Lot Number: 0232837110 Distribution: US Nationwide distribution in the states of FL and IN. Affected quantity: 2 units
- Hazard
- During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.