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Cordis Corporation recalls RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertens
Recalled August 26, 2015 · FDA recall Z-2405-2015 · Cordis
Hazard
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter. · FDA Class II
Units
98 units
Sold at
Distributed in Germany only.
Description
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.
Product
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →