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Incident · Recall

Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement

Intuitive recalled the da Vinci Single-Site Wristed Needle Driver (REF 478115) because the needle driver could dislodge or break, causing uncontrollable instrument movement. 317 units. Source: FDA Class 2 device recall Z-0406-2024, openFDA enforcement / accessdata.fda.gov.

Occurred 2023-10-06 · Intuitive Surgical · Investigated by FDA

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Track Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=203868

Common questions

What happened in Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement?
Intuitive recalled the da Vinci Single-Site Wristed Needle Driver (REF 478115) because the needle driver could dislodge or break, causing uncontrollable instrument movement. 317 units. Source: FDA Class 2 device recall Z-0406-2024, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on October 6, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement?
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 recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement?
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 recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (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

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

Methodology surface for Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement.

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Canonical ID 3f427e91-1f4c-4124-978d-8df4335b5cd1