Z-1464-2013Class II

da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to...

Name: Z-1464-2013 da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to...
Creator: Intuitive Surgical, Inc.
Published: 2013-05-06
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2013-05-06 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical... on 2013-05-06. FDA classified it as Class II and gives the reason as "Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1464-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-06-05
Terminated: 2014-04-15
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
FDA root cause: Use error
Action: Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
Quantity in commerce: 2101 consignees
Distribution: Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Model number 420262

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1464-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05

Product code NAY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)