🔍 RecallPedia

8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2014 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
  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:
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Product Codes/Lot Numbers:

Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Distribution:

Distributed in: US, FL, TX, NY, NV, OR, IN, UT, MA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0440-2015

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