Recall Z-0106-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-0106-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2021-08-06, terminated 2024-05-17. It names one FDA 510(k) clearance: K182188. Product: Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978. Reason: Potential for the sheath tip on the biopsy needle to separate from the sheath shaft..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-06
Terminated: 2024-05-17
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K182188 — Ion Endoluminal System; Flexision Biopsy NeedleIntuitive Surgical·cleared 2019-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

Reason for recall

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Data sourced from openFDA. This site is unofficial and independent of the FDA.