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Incident · Fatality

Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel

Intuitive Surgical reported one patient death and four serious injuries associated with incomplete staple line formation from 8mm SureForm 30 Gray Reloads used with the da Vinci Surgical System. The da Vinci robot returned a completed stapler fire, but the staple line was incomplete, causing the cut blood vessel to bleed and requiring conversion to open surgery.

Intuitive learned of the death in late December 2025 and issued a recall recommendation on March 11, 2026; the FDA classified it as a Class I recall on May 5, 2026.

Occurred 2025-12-20 · da Vinci (and Ion) · Intuitive Surgical · Surgical robots

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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.
Track Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel

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Sources (2)

  1. Fierce Biotech · https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death · 2026-03-20
  2. FDA · https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads · 2026-05-05

Common questions

What happened in Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?
Intuitive Surgical reported one patient death and four serious injuries associated with incomplete staple line formation from 8mm SureForm 30 Gray Reloads used with the da Vinci Surgical System. The da Vinci robot returned a completed stapler fire, but the staple line was incomplete, causing the cut blood vessel to bleed and requiring conversion to open surgery. Intuitive learned of the death in late December 2025 and issued a recall recommendation on March 11, 2026; the FDA classified it as a Class I recall on May 5, 2026.
When did this incident occur?
The incident is recorded as occurring on December 20, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?
da Vinci (and Ion) is the recorded robot involved in this incident.
Has anyone responded to Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?
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 Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?
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
unclassified
Unclassified source
1
primary-fda-database
FDA database

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

Methodology surface for Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel.

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Canonical ID 08da9279-8bb9-4e86-ae97-f0e268cc7307