Cordis Corporation: Medical Device Recall in 2015 - (Recall #: Z-2405-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 15, 2014

Date Posted: August 26, 2015

Recall Number: Z-2405-2015

Event ID: 70741

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.

Status: Terminated

Product Quantity: 98 units

Code Information:

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

Distribution Pattern:

Distributed in Germany only.

Voluntary or Mandated:

Voluntary: Firm initiated