RenLane Renal Denervation Catheter — Class II medical device recall Z-2405-2015
Terminated recall by Cordis Corporation, reported 2015-08-26. Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis val
| Recall number | Z-2405-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2014-04-15 |
| Classified | 2015-08-18 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2015-08-26 |
| Countries outside the US | DE |
| Quantity | 98 units |
| Lot numbers | 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, 15968813LA, 15976735L, 15976820L, 15976823L, 15978174L, 15978179L, 15978181L, 159784180L |
| Model numbers | 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, 15968813LA, D135601 |
| Expiration dates | 2014-08-31, 2014-09-30 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.