Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)
[RECALL]Dec 2, 2020 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Dec 2, 2020
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.)
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209213
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=209213
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Details
Incident Context & FAQ
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 at South Korea.
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.