Valleylab FT10 recallZ-0631-2024 · Covidien · initiated Nov 16, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
On November 16 and 20, 2023, Covidien LLC (Medtronic Company) issued a "Urgent: Medical Device Correction" 1. Immediately notify all personnel in all care environments in which the Valleylab" FT10 Energy Platform. 2. Update ValleylabTM FT10 Energy Platform to software version 4.0.4. For additional information see customer communication letter 3. Until the software is updated, the Valleylab" FT10 Energy Platform and LigaSure" devices can continue to be used as instructed in the User Guide and per your facility protocols. 4. Complete the attached Customer Confirmation Form and return it as directed to confirm your receipt and understanding of this information.
Recall details
- Recall number
- Z-0631-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 16, 2023
- Posted by the FDA
- Jan 3, 2024
- Recalling firm
- Covidien
- Quantity
- 47,901 units
- Product code
- GEI
- FDA submissions
- K191601
- Distribution
- Worldwide distribution - US: Nationwide and surrounding territories.
Product description
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Code information (models, lots, serial numbers)
Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- Valleylab FT10 VLFT10GENZDCovidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall12 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K191601 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Valleylab FT10 VLFT10GENCovidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death444 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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