🔍 RecallPedia

Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

Class I - Dangerous
🏥 Medical Devices Recalled: November 6, 2015 Terumo Medical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
  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:
Terumo Medical Corporation
Reason for Recall:
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.

Product Codes/Lot Numbers:

Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2033-2017

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