🔍 RecallPedia

Ion Endoluminal System, REF: 380748-65

Class I - Dangerous
🏥 Medical Devices Recalled: July 12, 2024 Intuitive Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014
  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:
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ion Endoluminal System, REF: 380748-65

Product Codes/Lot Numbers:

UDI: 00886874116234/ System Serial Number/System Cart Serial Number: EN1230/10591271; EN1241/10591273; EN1231/10583014

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2720-2024

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