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Incident · Recall

Intuitive Ion Endoluminal System recall (catheter / Flexision biopsy needle)

FDA recall(s) of Ion Endoluminal System components (catheter / Flexision biopsy needle); Class 2. Existence verified via FDA recall index entries (res.cfm id 209213/188906). Cap-flag: the specific recall reason, Z-number, units, and exact date were NOT verified to bar (FDA pages bot-blocked); a candidate MAUDE-sourced failure mode is a catheter vision-probe / distal-tip-ring issue, not confirmed as the official recall reason. Verified-but-thin pending a direct FDA pull.

Occurred 2025-02-14 · da Vinci (and Ion)

Machine-readable surfaces

Sources (1)

  1. FDA (recall record) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209213

Common questions

What happened in Intuitive Ion Endoluminal System recall (catheter / Flexision biopsy needle)?
FDA recall(s) of Ion Endoluminal System components (catheter / Flexision biopsy needle); Class 2. Existence verified via FDA recall index entries (res.cfm id 209213/188906). Cap-flag: the specific recall reason, Z-number, units, and exact date were NOT verified to bar (FDA pages bot-blocked); a candidate MAUDE-sourced failure mode is a catheter vision-probe / distal-tip-ring issue, not confirmed as the official recall reason. Verified-but-thin pending a direct FDA pull.
When did this incident occur?
The incident is recorded as occurring on February 14, 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 Intuitive Ion Endoluminal System recall (catheter / Flexision biopsy needle)?
da Vinci (and Ion) is the recorded robot involved in this incident.
Has anyone responded to Intuitive Ion Endoluminal System recall (catheter / Flexision biopsy needle)?
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 Ion Endoluminal System recall (catheter / Flexision biopsy needle)?
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 2026-06-04

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-06-04

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 Ion Endoluminal System recall (catheter / Flexision biopsy needle).

Canonical ID 985cc77b-b062-41c9-8f0e-f2c436c2b64f