Z-2427-2018Class II

LigaSure" Exact Dissector Nano Coated 20.6mm-21cm

Name: Z-2427-2018 LigaSure" Exact Dissector Nano Coated 20.6mm-21cm
Creator: Covidien LLC
Published: 2018-03-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-03-15 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where... on 2018-03-15. FDA classified it as Class II and gives the reason as "Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2427-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-07-12
Terminated: 2019-12-11
Recalling firm: Medtronic, Inc.
Product: LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
Root cause tag: packaging
FDA root cause: Other
Action: Medtronic Regional sent a notification letter to customers via overnight delivery. the letter identified the affected product, problem and actions to be taken. The letter request that you quarantine and return any unused products of the affected item codes and production lots. Unused products from the affected item codes should be returned. If you have distributed Covidien LigaSure" Exact Dissector listed, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes must be returned. The potentially affected product was shipped to your facility between November 2017 and February 2018.
Quantity in commerce: 936
Distribution: Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
Product codes and lots: Lot #s 72550127X 72770140X 72770141X 73000048X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2427-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2427-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-12

Product code FTL

K150091Class IIVersatex Monofilament MeshSofradim Production / cleared 2015-05-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)