_Incident · Recall_

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

Canonical ID: `ebbc656d-245e-44ef-a375-65a2e63bac52`

- **Occurred:** 2026-03-11
- **Kind:** `recall`
- **Status (derived):** active
- **Company:** [Intuitive Surgical](/companies/intuitive-surgical.md) (id: `e5127536-0ff2-4f0e-8488-64994cb2ffc7`)

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.

## 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.

### Who was involved in Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?

The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### 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.


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