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.
Reported: August 26, 2015 Initiated: April 15, 2014 #Z-2405-2015
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.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 98 units
- Distribution
- Distributed in Germany only.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cordis Corporation. Units affected: 98 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2015. Severity: Moderate. Recall number: Z-2405-2015.
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