_Incident · Recall_

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

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

- **Occurred:** 2025-02-14
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [da Vinci (and Ion)](/models/intuitive-da-vinci.md) (id: `45105ba4-1c1f-4121-9ad4-bb912db1dcfc`)

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.

## 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.


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