Z-1726-2017Class II

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese...

Name: Z-1726-2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese...
Creator: Intuitive Surgical, Inc.
Published: 2017-03-15
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2017-03-15 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic Surgery: The Intuitive... on 2017-03-15. FDA classified it as Class II and gives the reason as "Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool". 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-1726-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-15
Posted: 2017-04-05
Terminated: 2018-12-10
Recalling firm: Intuitive Surgical, Inc.
Product: STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic Surgery: The Intuitive Surgical 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: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive sent an Urgent Medical Device Correction (ISIFA2017-02-C) letter dated March 16, 2017 were sent by FED EX to be received on March 17, 2017. Letters advised users of the reason for the notification, risk to health, affected products with part numbers and a copy of Appendix A - proper use of the Stapler Release Kit (SRK). Customers were instructed to distribute a copy of the letter to all users at their facility, follow all instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and return the SRK to Intuitive Surgical through the Returned Material Authorization (RMA) process. Customers were also instructed to log into the da Vinci Online Community Field Action resource (US only) to read or complete any request actions related to this issue. In the case where the da Vinci online resource cannot be used (including outside he US), complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. Customers were asked to retain a copy of the letter with their Stapler User Manual and the acknowledgement form for their files. If you need further information or support concerning this notification , please contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected] Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.
Quantity in commerce: 2059 shipped - all languages
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela
Product codes and lots: Part number: 381395-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1726-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1714-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1715-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1716-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1717-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1718-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1719-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1720-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1721-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1722-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1723-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1724-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1725-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1726-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1727-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1728-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05
Z-1729-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05

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)