Z-2405-2015Class II

RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant...

Name: Z-2405-2015 RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant...
Creator: Cordis Corporation
Published: 2014-04-15
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2014-04-15 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to... on 2014-04-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2405-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-15
Posted: 2015-08-18
Terminated: 2015-08-26
Recalling firm: Cordis US Corp.
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.
Product code: MPB Catheter, Hemodialysis, Non-Implanted
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 98 units
Distribution: Distributed in Germany only.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-18

Product code MPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)