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.

Incident · Recall

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.)

Occurred 2020-12-02 · da Vinci (and Ion)

Track Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)Email on verified state changes. Cap-flags flow through.

Machine-readable surfaces

Markdown mirror: /incidents/intuitive-ion-recall-2020.md
JSON-LD: embedded in this page’s head
REST API: /v1/incidents/985cc77b-b062-41c9-8f0e-f2c436c2b64f
Data documentation: /data
Query this programmatically: Deploy MCP

Outcomes (1)

regulatory actionverified

Revision history (2)

2026-06-05 · outcome_class
2020-12-02 · date_correction : intuitive-ion-recall-2025 (occurred_at 2025-02-14, unverified) to intuitive-ion-recall-2020 (occurred_at 2020-12-02): Z-0489-2021 catheter + Z-0106-2022 Flexison needle

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (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.

Methodology: Verified · 1 source (1 primary) · last reviewed 2026-06-05

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-06-05

Sources by quality tier

1: primary-fda-database; FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

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