Z-1020-2019Class II

Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or...

Name: Z-1020-2019 Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or...
Creator: Covidien, PLC
Published: 2019-02-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-02-15 / Terminated / root cause: manufacturing process

FDA source

Covidien, PLC began a recall of Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device... on 2019-02-15. FDA classified it as Class II and gives the reason as "Potential for the sterile packaging to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1020-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-15
Posted: 2019-03-18
Terminated: 2020-06-17
Recalling firm: Medtronic, Inc.
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for the sterile packaging to be compromised
Root cause tag: manufacturing process
FDA 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 in commerce: 850 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1020-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-18

Product code GEI

K150735Class IIForce TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-footCovidien / cleared 2015-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)