Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged
[RECALL]Oct 23, 2020 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Oct 23, 2020
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Intuitive recalled the Ion Fully Articulating Catheter (REF 490105) because the distal tip ring could become dislodged during the bronchoscopy procedure. 454 units. Source: FDA Class 2 device recall Z-0489-2021, openFDA enforcement / accessdata.fda.gov.
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=184275
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=184275
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Details
Incident Context & FAQ
What happened in Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged?
Intuitive recalled the Ion Fully Articulating Catheter (REF 490105) because the distal tip ring could become dislodged during the bronchoscopy procedure. 454 units. Source: FDA Class 2 device recall Z-0489-2021, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on October 23, 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 recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged?
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 recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.