# Z-0106-2022 (us_fda)

Intuitive Ion Endoluminal System Flexison biopsy needle (19G, REF 490104-09 / 49004-10): sheath tip on the biopsy needle may separate from the sheath shaft. FDA Class II.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_recall
- Status: recalled
- Filing number: Z-0106-2022
- Filing date: 2021-08-06
- Decision date: 2021-10-20
- 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-0106-2022](https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0106-2022)

_Canonical URL: /regulatory-filings/fda-recall-intuitive-ion-flexison-needle-2021. HTML version: [/regulatory-filings/fda-recall-intuitive-ion-flexison-needle-2021](/regulatory-filings/fda-recall-intuitive-ion-flexison-needle-2021)._