FDA (Devices) recall action 78129
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.