Recall Z-2950-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-2950-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-10

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2020-06-10. It names one FDA 510(k) clearance: K182188. Product: ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).. Reason: One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-06-10
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 Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).

Reason for recall

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

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