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) · Intuitive Surgical

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.

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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) by Intuitive Surgical 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 2026-06-24

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-06-24

Sources by quality tier

1: primary-fda-database; FDA database

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

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