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

FDA device recall Z-2405-2015 · posted 2015-08-18 · Terminated

Recall details

Recalling firm

Cordis Corporation

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.

Action taken

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

MPB

Quantity affected

98 units

Distribution

Distributed in Germany only.

Date initiated

2014-04-15

Date posted

2015-08-18

Date terminated

2015-08-26

Location

Miami Lakes, FL