Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Destination Renal Guiding Sheath Intended for the introduction of interventional Recalled by Terumo Medical Corporation Due to Based on internal investigation and testing that revealed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Medical Corporation directly.
Affected Products
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Quantity: 5,252 eaches
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Medical Corporation
Terumo Medical Corporation has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report