FDA Medical Device Recalls (openFDA)
Cordis Corporation: 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.
- Recall number
- Z-2405-2015
- Recalling firm
- Cordis Corporation
- 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.
- Status
- Terminated
- Initiated
- 2014-04-15
- Posted
- 2015-08-18
- Terminated
- 2015-08-26
- 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.
- 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
- 98 units
- Distribution
- Distributed in Germany only.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MPB
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28