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FDANovember 6, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

terumo medicalterumo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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