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Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate ...

FDA Device Recall #Z-0489-2021 — Class II — October 23, 2020

Recall Summary

Recall Number Z-0489-2021
Classification Class II — Moderate risk
Date Initiated October 23, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Intuitive Surgical, Inc.
Location Sunnyvale, CA
Product Type Devices
Quantity 454 catheters

Product Description

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

Reason for Recall

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

Distribution Pattern

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.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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