Force Triverse recallZ-1020-2019 · Covidien, PLC · initiated Feb 15, 2019
Terminated
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, PLC 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
Potential for the sterile packaging to be compromised
FDA root cause category: Equipment maintenance
What the company is doing
Medtronic notified via letter by Federal Express and/or certified mail on February 15, 2019. The letter informs customers of the recall of one production lot of Covidien Force TriVerse" electrosurgical devices 10 cord due to the potential for the sterile packaging to be compromised and the actions they should take. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Force TriVerse" electrosurgical devices 10 cord. " Complete the Recalled Product Return Form
Recall details
- Recall number
- Z-1020-2019
- Status
- Terminated
- Initiated by the company
- Feb 15, 2019
- Recalling firm
- Covidien, PLC
- Quantity
- 850 units
- Product code
- GEI
- FDA submissions
- K150735
- Distribution
- US Nationwide Distribution
Product description
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
Code information (models, lots, serial numbers)
Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Force Triverse FT3000Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall27 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K150735 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Force Triverse FT3000DBCovidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 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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