Events

Recall of RenLane Renal Denervation Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70741
  • Event Risk Class
    Class 2
  • Event Number
    Z-2405-2015
  • Event Initiated Date
    2014-04-15
  • Event Date Posted
    2015-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134590
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, hemodialysis, non-implanted - Product Code MPB
  • 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.
  • Action
    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.

Device

RenLane Renal Denervation Catheter
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Germany only.
  • 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.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA