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Medtronic Recalls Octopus Nuvo Tissue Stabilizer Due to Assembly Issue

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.

Official notice
Medtronic Perfusion SystemsHealth & Personal CareMedical DevicesUDI-DI: 00763000543693Lot Number: 0232837110

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 13, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 13, 2026
Hazard Level
HIGH
Brand
Medtronic Perfusion Systems
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medtronic Perfusion Systems
Product type
Tissue Stabilization System
Model numbers
UDI-DI: 00763000543693, Lot Number: 0232837110
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 13, 2026

  2. Reported by FDA DEVICE

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

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

About This Product

The Octopus Nuvo Tissue Stabilizer is designed for use in surgical procedures to stabilize tissue during operations. It is used by healthcare providers to enhance the safety and effectiveness of surgical interventions.

Why This Is Dangerous

The assembly issue poses a potential risk if the tubing is not positioned correctly, which can lead to improper operation of the device during surgery. This could compromise patient safety during critical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must act quickly to stop using the product, potentially leading to delays in surgical procedures and requiring alternative solutions.

Practical Guidance

How to identify if yours is affected

  1. Check the product number TSMICS1 and lot number 0232837110.
  2. Verify if your device has the incorrect tubing assembly.
  3. Look for any communication from Medtronic regarding the recall.

Where to find product info

The product number and lot number can typically be found on the device packaging or accompanying documentation.

What timeline to expect

Expect a response within 4-6 weeks for any refund or replacement requests.

If the manufacturer is unresponsive

  • Follow up with Medtronic directly via phone or email.
  • Document all correspondence and keep records.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Ensure proper training on the use of devices to prevent misuse.

Documentation advice

Keep records of all communications with the manufacturer and any relevant receipts.

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Product Details

The Octopus Nuvo Tissue Stabilizer, Product Number TSMICS1, is a disposable tissue stabilization system. It was distributed nationwide in Florida and Indiana.

Key Facts

  • Recall date: January 13, 2026
  • Two units affected
  • Distribution in Florida and Indiana
  • High hazard level identified

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeTissue Stabilization System
Sold At
Unknown

Product Details

Model Numbers
UDI-DI: 00763000543693
Lot Number: 0232837110
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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