[pending] Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Pending LLM rewrite. Source: FDA_DEVICE Z-1473-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Devices
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 (2)
- UDI-DI: 00763000543693
- Lot Number: 0232837110
Distribution
Distributed nationwide across the United States.
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