Reported Aug 26, 2015 · Terminated
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number
D135601 Lots #'s 15958389LA15959088LA15959090LA15968753LA15968806LA15968810LAand 15968813LAwith Exp Date 8/31/2014 Lots #'s 15976735L15976820L15976823L15978174L15978179L159784180Land 15978181L with Exp Date 9/30/2014
- Model Number
- Amount recalled
- 98 units
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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