Z-0404-2018Class II

daVinci X EndoWrist(R) Stapler 45, REF 470298

Name: Z-0404-2018 daVinci X EndoWrist(R) Stapler 45, REF 470298
Creator: Intuitive Surgical, Inc.
Published: 2017-09-19
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2017-09-19 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories... on 2017-09-19. FDA classified it as Class II and gives the reason as "Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0404-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-19
Posted: 2018-01-23
Terminated: 2024-01-30
Recalling firm: Intuitive Surgical, Inc.
Product: daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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 the same staple line or tissue buttressing material (natural synthetic).
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will be provided for remaining uses on affected instruments returned to Intuitive Surgical. 2.Please log into the da Vinci Online Community field action resource to read and/or complete any requested actions related to this issue. a. https://www.davincisurgerycommunity.com/ 3.If you cannot access the da Vinci Online Community field action resource, please complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instructions contained in the Acknowledgement Form. 4.Please retain a copy of this letter and a copy of the Acknowledgement Form for your files."
Quantity in commerce: 60 units
Distribution: US Nationwide Distribution
Product codes and lots: UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0404-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-23

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)