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Incident · Recall

Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables

Intuitive recalled the da Vinci 8mm Large Needle Driver (REF 470006) over frayed or broken grip cables that could cause loss of instrument control during surgery. 10,603 units. Source: FDA Class 2 device recall Z-0849-2025, openFDA enforcement / accessdata.fda.gov.

Occurred 2024-12-19 · Intuitive Surgical · Investigated by FDA

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Track Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=211924

Common questions

What happened in Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables?
Intuitive recalled the da Vinci 8mm Large Needle Driver (REF 470006) over frayed or broken grip cables that could cause loss of instrument control during surgery. 10,603 units. Source: FDA Class 2 device recall Z-0849-2025, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on December 19, 2024 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 8mm Large Needle Driver over frayed or broken grip cables?
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 8mm Large Needle Driver over frayed or broken grip cables?
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 8mm Large Needle Driver over frayed or broken grip cables?
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 8mm Large Needle Driver over frayed or broken grip cables.

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Canonical ID 558e867d-cd05-4a78-9321-3b4bd554d270