FDA Medical Device Recalls (openFDA)
BioSense Webster, Inc.: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
- Recall number
- Z-0368-2010
- Recalling firm
- BioSense Webster, Inc.
- Product
- Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
- Status
- Terminated
- Initiated
- 2008-10-02
- Posted
- 2009-11-19
- Terminated
- 2009-11-23
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- ["P990025S009"]
- Product code
- LPB
- Firm FEI
- 3003248396
- Firm city
- Juarez
- Firm state
- Chihuahua
- Firm country
- Mexico
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28