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Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable… recallZ-0369-2010 · BioSense Webster, Inc. · initiated Oct 2, 2008

Terminated All recalls posted in November 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from BioSense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0369-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 2, 2008
Posted by the FDA
Nov 19, 2009
Recalling firm
BioSense Webster, Inc.
Quantity
2180 Units
Product code
LPB
FDA submissions
P990025
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

Product description

Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02

Code information (models, lots, serial numbers)

All lot numbers

Other devices under the same FDA submission

13 devices cleared under P990025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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