da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments
[RECALL]Oct 7, 2022 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Oct 7, 2022
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA recall Z-0340-2023 (Class II; initiated Oct 7 2022): potential staple deployment failure and intraoperative device-fragment generation on da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads. Distinct from the 2026 gray-reload Class I death recall (different year/class/failure mode).
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://regdatalab.com/recall/Z-0340-2023
https://regdatalab.com/recall/Z-0340-2023
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=196688
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=196688
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Details
Incident Context & FAQ
What happened in da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
FDA recall Z-0340-2023 (Class II; initiated Oct 7 2022): potential staple deployment failure and intraoperative device-fragment generation on da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads. Distinct from the 2026 gray-reload Class I death recall (different year/class/failure mode).
When did this incident occur?
The incident is recorded as occurring on October 7, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.