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Incident · Recall

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

Intuitive recalled the da Vinci 8mm Mega SutureCut Needle Driver (REF 471309) over frayed or broken grip cables that could cause loss of instrument control during surgery. 88,840 units. Source: FDA Class 2 device recall Z-0880-2025, openFDA enforcement / accessdata.fda.gov.

Occurred 2024-12-19 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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

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Sources (2)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=211978
  2. https://www.intuitive.com/en-us/products-and-services/da-vinci

Common questions

What happened in Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables?
Intuitive recalled the da Vinci 8mm Mega SutureCut Needle Driver (REF 471309) over frayed or broken grip cables that could cause loss of instrument control during surgery. 88,840 units. Source: FDA Class 2 device recall Z-0880-2025, 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.
What robot was involved in Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive recalls da Vinci 8mm Mega SutureCut 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 Mega SutureCut 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 · 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 recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables.

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Canonical ID af76a56d-a783-4c6d-bbd5-33a379f186b0