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Incident · Recall

Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death

In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.

Occurred 2026-03-11 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (2)

  1. U.S. FDA · https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-surgical-stapler-issue-intuitive-surgical · 2026-03-01
  2. FierceBiotech · https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death · 2026-03-20

Status history

  • Active · 2026-07-18 · agent:recon

Common questions

What happened in Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.
When did this incident occur?
The incident is recorded as occurring on March 11, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
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 Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death.

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