# Z-0489-2021 (us_fda)

Intuitive Ion Endoluminal System fully-articulating catheter (REF 490105): distal tip ring may become dislodged during the procedure. FDA Class II.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_recall
- Status: recalled
- Filing number: Z-0489-2021
- Filing date: 2020-10-23
- Decision date: 2020-12-02
- Verification posture: verified

## Applicant

- [Intuitive Surgical](/companies/intuitive-surgical.md)

## Covered models (1)

- [Ion Endoluminal System](/models/intuitive-ion.md)

## Related incident

_Recall-is-both seam: this filing is paired with its incident-layer companion when the filing is a recall._

- [Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)](/incidents/intuitive-ion-recall-2020.md)

## Sources (1)

- [https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0489-2021](https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0489-2021)

_Canonical URL: /regulatory-filings/fda-recall-intuitive-ion-catheter-2020. HTML version: [/regulatory-filings/fda-recall-intuitive-ion-catheter-2020](/regulatory-filings/fda-recall-intuitive-ion-catheter-2020)._