FDA Medical Device Recalls (openFDA)
Covidien, PLC: 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
- Recall number
- Z-1020-2019
- Recalling firm
- Covidien, PLC
- Product
- 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
- Status
- Terminated
- Initiated
- 2019-02-15
- Posted
- not on file
- Terminated
- 2020-06-17
- Reason
- Potential for the sterile packaging to be compromised
- Root cause
- Equipment maintenance
- Action
- 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
- Quantity
- 850 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081
- 510(k) numbers
- ["K150735"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1717344
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28