Regulatory filing

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.

fda recall · recalled · decided 2021-10-20

Machine-readable surfaces

Markdown mirror: /regulatory-filings/fda-recall-intuitive-ion-flexison-needle-2021.md
JSON-LD: embedded in this page’s head
REST API: /v1/filings/732fc73e-f12b-4427-a68d-fca151946144
Revision history: /regulatory-filings/fda-recall-intuitive-ion-flexison-needle-2021/history
Data documentation: /data

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

Covered models (1)

Ion Endoluminal System

Sources (1)

https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0106-2022

Deploy Watch

Track Z-0106-2022 (us_fda).

We notify you when the filing status changes or related filings, incidents, or litigations surface.

Identity

732fc73e-f12b-4427-a68d-fca151946144