🔍 RecallPedia

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

Class I - Dangerous
🏥 Medical Devices Recalled: June 10, 2020 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    All lots.
  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:
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.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

Product Codes/Lot Numbers:

All lots.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2949-2020

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