Z-2405-2015 Class II Terminated
FDA device recall Z-2405-2015 was initiated by Cordis Corporation on Apr 15, 2014 and is designated Class II. 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… The recall status is terminated (terminated Aug 26, 2015). Affected quantity: 98 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 26, 2015
- Initiation Date
- Apr 15, 2014
- Termination Date
- Aug 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 units
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.
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.
Distribution Pattern
Distributed in Germany only.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2405-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026