FDAFDA · Food and drugs·Recall number Z-0058-2018
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Published November 8, 2017 · Recall initiated: September 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China
- Lot
- 17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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