Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02

FDA device recall Z-0368-2010 · posted 2009-11-19 · Terminated

Recall details

Recalling firm

BioSense Webster, Inc.

Reason for recall

Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u

Action taken

The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy." If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement. Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.

Root cause

Process control

Status

Terminated

Product code

LPB

Quantity affected

2559 units

Distribution

CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI

Date initiated

2008-10-02

Date posted

2009-11-19

Date terminated

2009-11-23

Location

Juarez, Chihuahua, Mexico