FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads 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 is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
- Recall number
- Z-2676-2016
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads 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 is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
- Status
- Terminated
- Initiated
- 2016-07-14
- Posted
- 2016-08-26
- Terminated
- 2017-01-03
- Reason
- Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
- Root cause
- Nonconforming Material/Component
- Action
- Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South America: 800-876-1310, option 3 (6AM to 5PM PST) Email: customersupport..servicesupport@intusurg.com Europe, Middle East, Asia and Africa Phone: 800-821-2020 or +41 21 821 2020 Email: ics@intusurg.com Customers were also instructed to complete the attached Return Acknowledgement Form and submit via email to Regulatory Compliance at isi.compliance@intusurg.com or by fax to +1 (408) 523-0619. For questions regarding this recall call 408-523-2100. 10-31-16 Update: Monthly status update states that an additional 93 instruments have been identified and an additional communication will be sent to these sites in Mid November 2016,
- Quantity
- 875 instruments (827 a la carte + 48 in kits) total, all models
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
- Lot, serial or model codes
- All model 470430
- 510(k) numbers
- ["K140553"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28