Z-0368-2010

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

Name: Z-0368-2010 Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 &...
Creator: BioSense Webster, Inc.
Published: 2008-10-02
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2008-10-02 / Terminated / root cause: manufacturing process

FDA source

BioSense Webster, Inc. began a recall of Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02 on 2008-10-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0368-2010
Status: Terminated
Initiated: 2008-10-02
Posted: 2009-11-19
Terminated: 2009-11-23
Recalling firm: Biosense Webster Inc
Product: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
Product code: LPB Cardiac Ablation Percutaneous Catheter
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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
Product codes and lots: All lot numbers

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)