Reported Nov 8, 2017 · Terminated
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
- THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
- Lot codes and dates
- l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L ll 7685772L 17689372L 17680198L 17685795L 17689380L 17680199L l 7685805L 17689381L 17682731L l
7689369L17677144L17685763L17689370L17680082L17685770L17689371L17680149L
l 7689396L 17682790L l7685806L17689387L17682732L17685816L17689390L17682733L17685843L17689392L17682789L17685844L
l 7682855L l 7685887L l 7689445L 17682858L 17685901L 17689447L l 7682910L 17685902L 17689449L l 7682911L l 7689355L l7685859L17689403L17682820L17685883L17689405L17682853L17685885L17689413L17682854L17685886L17689444L
l 7689485L l 7689535L l7689451L17682912L17689358L17689461L17689462L17689532L17690548L17689477L17689533Ll7690549L17689479L17689534L17690550L
l7690551L17689486L17689536L17692025L17689487L17689537L17692026L17689488L17689538L17692027L17689489L17689539L17692028L17689490L17689540L17692037L17689491L17689541L17692053L17689492Ll7690527L17692054L17689493L
l 7692061L 17689506L 17690537L 17692062L 17689512L l 7690539L 17692063L l 7689529L 17690540L 17692064L 17689530L 17690541L 17692065L 1768953 lL 17690542L 17692066L 17692070L l7690528L17692057L17689494L17690529L17692058Ll7689496L17690530L17692059Ll7689497L17690531L17692060L17689505L17690533L
l 7698339L l7692193L17695495L17698306L17698457L17692099L17692194L17695519L17698307Ll7698458L17692101L17692196L17695520L17698308L17698460L17692102L17692197L17695522L
l 7695525L l7698461L17692104L17692205L17695523L17698340L17701761L17692105L17692209L17695524L17698341L17701765L17692107L17692226L
l 7698347L l7698343L17701766L17692109L17692228L17695526L17698344L17701769L17692110L17692229L17695564L
lL l7695623L 17698378L 17701774L 17692140L 17692237L l 7695626L 17698382L 17701775L 17692142L l 7692238L 17695628L l 7698383L 17701798L 17692149L 17695427L 17695633L l7701771L17692116L17692230L17695565L17698348L17701773L17692139L1769223
l 7697887L 17698417L 17701802L l 7692155L 17695456L l 7697888L 17698418L 17701806L 17692159L 17695458L 17698298L 17698420L l 7701810L 17692186L 17695489L 17698299L l7698423L 17701812L 17692189L l 7695491L 17698302L 17698425L 17701834L 17692191L 17695492L l 7698303L 17698454L 17701842L7698384L17701799L17692150L17695453L17697886L17698385L17701801L17692151L17695455L
- l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L l
- Amount recalled
- 1962 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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