Recall Z-2405-2015— Cordis Corporation
Class II · Terminated
Class II FDA medical device recall by Cordis Corporation, initiated 2014-04-15, terminated 2015-08-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Cordis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-15
- Terminated
- 2015-08-26
- Firm location
- Miami Lakes, FL, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.