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Recall Observatory FDA recall evidence

Device 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.

Z-2405-2015

April 15, 2014

Class II

Product summary

Firm
Cordis Corporation
Event
Event 70741
Status
Terminated
Classification
Class II
Quantity
98 units
Official record key
device-enforcement:Z-2405-2015

Official wording

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.

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

Distribution pattern: Distributed in Germany only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.