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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Da Vinci 5 Surgical Consoles Recalled for Foot Tray Pedal Malfunction

Agency Publication Date: March 12, 2025
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Summary

Intuitive Surgical, Inc. has recalled 439 Da Vinci 5 (dV5) Surgical Console foot tray pedal assemblies (Model 380730) because the pedal spring can fail. This defect causes the pedal to remain in the pressed position even after the surgeon releases it. The recall includes all dV5 consoles and foot tray assemblies manufactured before December 20, 2024, following an increase in complaints regarding this issue. Healthcare facilities should stop using affected equipment and contact the manufacturer for a repair or replacement.

Risk

A pedal that remains stuck in the pressed position can cause surgical instruments to activate or move unintentionally. This malfunction creates a risk of accidental tissue damage or other surgical complications while a patient is undergoing a procedure.

What You Should Do

  1. This recall affects Da Vinci 5 surgical consoles and dV5 Foot Tray Pedal assemblies (Model 380730) with Unique Device Identifier (UDI) 00886874119747 that were manufactured before December 20, 2024.
  2. Stop using the recalled device immediately to prevent unintended surgical instrument activation.
  3. Contact Intuitive Surgical or your authorized medical distributor to arrange for the return, replacement, or corrective repair of the affected foot tray assembly.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Firm initiated voluntary recall for correction or replacement.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedalsby Da Vinci 5
Model / REF:
380730
UDI:
00886874119747
Date Ranges: Manufactured prior to 12/20/2024

Includes all da Vinci dV5 consoles and foot trays assemblies manufactured prior to December 20, 2024.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96345
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Intuitive Surgical direct sales; Authorized medical distributors
Manufactured In: United States
Units Affected: 439 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.