Z-1469-2013Class II

Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm

Name: Z-1469-2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm
Creator: Covidien LP
Published: 2013-05-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-05-06 / Terminated / root cause: design

FDA source

Covidien LP began a recall of Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a... on 2013-05-06. FDA classified it as Class II and gives the reason as "Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1469-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-06-05
Terminated: 2014-08-12
Recalling firm: Medtronic, Inc.
Product: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Root cause tag: design
FDA root cause: Device Design
Action: Covidien sent an Urgent Medical Device Recall letter dated May 6, 2013,via federal express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the product and return all inventory to Covidien Surgical Solutions, 195 McDermott Road, North Haven, CT 06473. Customers were requested to return completed Response Form. Customers with questions were instructed to contact their Covidien representative or Covidien Customer Service, Monday through Friday, Sam - 6:30pm ET, at (800) 962-9888, option 1, and then option 2. For questions regarding this recall call 203-492-8165.
Quantity in commerce: 126925 units
Distribution: Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
Product codes and lots: Lot Numbers: N2H0353X through N3D0033X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1469-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1467-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1468-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1469-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1470-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1471-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1472-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05

Product code GCJ

K112349Class IIVersaport V2 Bladeless Optiical Trocar And/or Versaport Bladeless Optical TrocarCovidien, Formerly US Surgical A Divison of Tyco H / cleared 2011-09-01

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)