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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

Covidien: Valleylab FT10 Energy Platforms Recalled for Software-Related System Failure

Agency Publication Date: January 3, 2024
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Summary

Covidien is recalling 47,901 units of the Covidien Valleylab FT10 and FT Series Energy Platforms due to a software issue that can cause the system to display an error and become completely inoperable. This defect prevents the medical device from being used during surgical procedures, which could lead to surgical delays. The affected systems include models VLFT10GEN, DLVLFT10GEN, and VLFT10GENZD running software versions 4.0.1, 4.0.2, or 4.0.3.

Risk

The software error can cause the energy platform to fail or stop working entirely, which may result in a delay of critical surgical treatment or the need for alternative medical equipment during a procedure. No specific injuries were reported in the recall data, but device failure during surgery poses a moderate risk to patient safety.

What You Should Do

  1. Identify if your device is affected by checking the model and reference numbers on the equipment label: VLFT10GEN, DLVLFT10GEN, or VLFT10GENZD.
  2. Verify the software version currently installed on the system; this recall specifically impacts software versions 4.0.1, 4.0.2, and 4.0.3.
  3. Check the Universal Device Identifier (UDI) numbers on your system to confirm a match with the following: 10884521516328 (VLFT10GEN), 10884521787056 (DLVLFT10GEN), or 10884521640474 (VLFT10GENZD).
  4. Contact your healthcare provider or Covidien/Medtronic directly to discuss the software issue and obtain necessary technical support or potential software updates.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer-initiated correction due to software error.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Covidien Valleylab FT10, FT Series Energy Platform (REF: VLFT10GEN)
Model / REF:
VLFT10GEN
UPC Codes:
10884521516328
Lot Numbers:
Software: v4.0.1
Software: v4.0.2
Software: v4.0.3
Product: Covidien Valleylab FT10, FT Series Energy Platform (REF: DLVLFT10GEN)
Model / REF:
DLVLFT10GEN
UPC Codes:
10884521787056
Lot Numbers:
Software: v4.0.1
Software: v4.0.2
Software: v4.0.3
Product: Covidien Valleylab FT10, FT Series Energy Platform (REF: VLFT10GENZD)
Model / REF:
VLFT10GENZD
UPC Codes:
10884521640474
Lot Numbers:
Software: v4.0.1
Software: v4.0.2
Software: v4.0.3

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93561
Status: Active
Manufacturer: Covidien
Sold By: Authorized Medtronic/Covidien distributors
Manufactured In: United States
Units Affected: 47,901 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.