—#134590

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.

FDA product code: MPB — Catheter, Hemodialysis, Non-Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Model Number: D135601 Lots #'s 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, and 15968813LA, with Exp Date 8/31/2014 Lots #'s 15976735L, 15976820L, 15976823L, 15978174L, 15978179L, 159784180L, and 15978181L with Exp Date 9/30/2014

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Cordis sent an Urgent Field Safety Notice dated April 15, 2014 providing additional labeling to their consignees in Germany only, with a follow-up letter on August 4, 2014. Cordis explained When deploying the catheter via a compatible arterial access device, if a Tuohy-Borst type adjustable hemostasis valve is used, ensure the valve is fully open before insertion or withdrawal of the catheter. This is especially important, since the helical tip at the distal end of the RENLANE Renal Denervation Catheter has a larger diameter compared to the proximal catheter shaft. Although the event was not a Removal, all lots involved have expired. The product is no longer commercialized, and was never commercialized beyond the 10 customers in Germany.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Distributed in Germany only.

Timeline

Recall initiated: 2014-04-15
Posted by FDA: 2015-08-18
Terminated: 2015-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.