Medtronic recalled two units of the Octopus Nuvo Tissue Stabilizer on January 13, 2026, after identifying an assembly issue. The tubing was incorrectly positioned, posing a high hazard risk to patients. Healthcare providers and patients must stop using the device immediately to prevent potential complications.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Perfusion Systems or your healthcare provider for instructions. Notification method: Letter
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The Octopus Nuvo Tissue Stabilizer, Product Number TSMICS1, is a disposable tissue stabilization system. It was distributed nationwide in Florida and Indiana.
The assembly issue involves incorrect tubing positioning. The short tube attached to the bottom of the canister and the long tube attached to the top, conflicting with designed specifications.
There are no reported incidents or injuries related to this recall. However, due to the assembly issue, the risk to patient safety is classified as high.
Patients and healthcare providers should stop using the device immediately. Contact Medtronic Perfusion Systems or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1473-2026 or contact Medtronic directly.
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