🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: October 23, 2020 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Intuitive Surgical, Inc.
Reason for Recall:
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0489-2021

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