Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft
[RECALL]Aug 6, 2021 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Aug 6, 2021
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 Flexision 19G Biopsy Needle (REF 490104-09 / -10) because the sheath tip could separate from the sheath shaft. 1,625 units. Source: FDA Class 2 device recall Z-0106-2022, 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=188906
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=188906
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Details
Incident Context & FAQ
What happened in Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
Intuitive recalled the Ion Flexision 19G Biopsy Needle (REF 490104-09 / -10) because the sheath tip could separate from the sheath shaft. 1,625 units. Source: FDA Class 2 device recall Z-0106-2022, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on August 6, 2021 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 Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
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 Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
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 Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.