_Incident · Recall_

# Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)

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

- **Occurred:** 2020-12-02
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [da Vinci (and Ion)](/models/intuitive-da-vinci.md) (id: `45105ba4-1c1f-4121-9ad4-bb912db1dcfc`)

Two FDA Class II recalls of Intuitive Ion Endoluminal System components, both by Intuitive Surgical, Inc.: the fully-articulating catheter (Z-0489-2021, posted 2020-12-02; distal tip ring may dislodge) and the Flexison biopsy needle (Z-0106-2022, posted 2021-10-20; sheath tip may separate). Both verified via openFDA. (Prior generic 2025 anchoring corrected; the FDA res.cfm index IDs 209213/188906 are retired/unresolvable, but the underlying recalls are corroborated.)

## 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 recalls (fully-articulating catheter and Flexison biopsy needle)?

Two FDA Class II recalls of Intuitive Ion Endoluminal System components, both by Intuitive Surgical, Inc.: the fully-articulating catheter (Z-0489-2021, posted 2020-12-02; distal tip ring may dislodge) and the Flexison biopsy needle (Z-0106-2022, posted 2021-10-20; sheath tip may separate). Both verified via openFDA. (Prior generic 2025 anchoring corrected; the FDA res.cfm index IDs 209213/188906 are retired/unresolvable, but the underlying recalls are corroborated.)

### When did this incident occur?

The incident is recorded as occurring on December 2, 2020 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 recalls (fully-articulating catheter and Flexison biopsy needle)?

da Vinci (and Ion) is the recorded robot involved in this incident.

### Has anyone responded to Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison 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 recalls (fully-articulating catheter and Flexison biopsy needle)?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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