Z-2348-2016Class II

STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist...

Name: Z-2348-2016 STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist...
Creator: Intuitive Surgical, Inc.
Published: 2016-07-14
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-07-14 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler... on 2016-07-14. FDA classified it as Class II and gives the reason as "An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2348-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-08-05
Terminated: 2017-01-03
Recalling firm: Intuitive Surgical, Inc.
Product: STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
Root cause tag: software
FDA root cause: Software design
Action: Field Safety Notifications - Urgent Medical Device Corrections and Removal letters were sent on July 15, 2016 (dated July 14, 2016 advised users of the Stapler Firing Failed message and actions to take should the message be received.
Quantity in commerce: 2065 total
Distribution: US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05
Z-2349-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05
Z-2350-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05

Product code NAY

K140553Class IIEndowrist Stapler 45 and Stapler 45 ReloadsIntuitive Surgical, Inc. / cleared 2014-07-25

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)