Z-0489-2021Class II

Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 -

Name: Z-0489-2021 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 -
Creator: Intuitive Surgical, Inc.
Published: 2020-10-23
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2020-10-23 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a... on 2020-10-23. FDA classified it as Class II and gives the reason as "The distal tip ring of the fully articulating catheter may become dislodged during the procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0489-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-11-25
Terminated: 2022-12-05
Recalling firm: Intuitive Surgical, Inc.
Product: Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/23/2020, the firm sent an "Urgent Medical Device Correction" Notification to customers via a courier service informing them of the potential for the distal tip ring to become dislodged. All lots of the affected product (VER: 08) are potentially impacted. The Recalling Firm is instructing customers to: 1.) Prior to start of the procedure, with the Vision Probe fully inserted and connected to the back end of the Catheter, ensure that the Vision Probe does not extend beyond the Catheter. a. If the Vision Probe extends past the Catheter do not use the Catheter in a procedure. 2.) At the end of the procedure, confirm that the distal tip ring is still intact (with the Vision Probe fully inserted and connected to the backend of the Catheter, confirm that the Vision Probe does not extend beyond the Catheter. a. If the Vision Probe extends past the Catheter, perform fluoroscopy to ensure that the Catheter distal tip ring does not remain in the patient. In addition, please follow the instructions outlined in the Ion System, Instrument and Accessories User Manual (PN 553990), specifically: 1.) Inspect all instruments and accessories for potential damage prior to clinical use. 2.) Use only compatible Cook Captura biopsy forceps. Failure to use compatible forceps may result in stuck forceps or Catheter damage. a. Ensure that the Cook Captura biopsy forceps are fully closed when withdrawing into the Catheter after biopsy. b. Slowly insert and retract (do not use excessive force or rapidly withdraw) the Cook Captura biopsy forceps into the Catheter. If the Catheter distal tip ring is missing at any point during inspection, contact Customer Service immediately and return the Catheter and the distal tip ring, if available, through the standard RMA process. In addition, the Recalling Firm is asking customers to: 1. Inform necessary hospital personnel about this issue 2. Complete the attached Acknowledgement Form and return via email [email protected] Att
Quantity in commerce: 454 catheters
Distribution: US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.
Product codes and lots: Model Number: 490105-08 UDI: 00886874116258 Lot/Serial Number: All S10181217 S10190103 S10190424 S10190424 S10190424 S10190531 S10190531 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190610 S10190610 S10190625 S10190625 S10190710 S10190802 S10190802 S10190823 S10190823 S10190823 S10190823 S10190823 S10190829 S10190829 S10190829 S10190829 S10190829 S10190829 S10190911 S10190911 S10190911 S10190911 S10190911 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191203 S10191203 S10191203 S10191203 S10191203 S10191203 S10191210 S10191210 S10191210 S10191210 S10191210 S10191216 S10191216 S10191216 S10191217 S10191217 S10191217 S10191231 S10191231 S10191231 S10191231 S10191231 S10191231 S10200107 S10200107 S10200107 S10200107 S10200107 S10200107 S10200110 S10200110 S10200110 S10200110 S10200110 S10200110 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200227 S10200227 S10200304 S10200304 S10200304 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200323 S10200323 S10200323 S10200323 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200403 S10200403 S10200403 S10200403 S10200403 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200820 S10200820 S10200820 S10200825 S10200825 S10200825

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0489-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25

Product code EOQ

K182188Class IIIon Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical / cleared 2019-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)