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Terumo Medical Corporation recalls Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the huma
Recalled May 10, 2017 · FDA recall Z-2033-2017 · Terumo Medical
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. · FDA Class II
Units
5,252 eaches
Sold at
Nationwide Distribution.
Description
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.
Product
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Manufacturer(s)
Terumo Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →