🔍 RecallPedia

THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S

Class I - Dangerous
🏥 Medical Devices Recalled: September 6, 2017 Biosense Webster Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L l 7689369L 17677144L 17685763L 17689370L 17680082L 17685770L 17689371L 17680149L l 7685772L 17689372L 17680198L 17685795L 17689380L 17680199L l 7685805L 17689381L 17682731L l 7685806L 17689387L 17682732L 17685816L 17689390L 17682733L 17685843L 17689392L 17682789L 17685844L l 7689396L 17682790L l 7685859L 17689403L 17682820L 17685883L 17689405L 17682853L 17685885L 17689413L 17682854L 17685886L 17689444L l 7682855L l 7685887L l 7689445L 17682858L 17685901L 17689447L l 7682910L 17685902L 17689449L l 7682911L l 7689355L l 7689451L 17682912L 17689358L 17689461L 17689462L 17689532L 17690548L 17689477L 17689533L l7690549L 17689479L 17689534L 17690550L l 7689485L l 7689535L l 7690551L 17689486L 17689536L 17692025L 17689487L 17689537L 17692026L 17689488L 17689538L 17692027L 17689489L 17689539L 17692028L 17689490L 17689540L 17692037L 17689491L 17689541L 17692053L 17689492L l7690527L 17692054L 17689493L l 7690528L 17692057L 17689494L 17690529L 17692058L l7689496L 17690530L 17692059L l7689497L 17690531L 17692060L 17689505L 17690533L l 7692061L 17689506L 17690537L 17692062L 17689512L l 7690539L 17692063L l 7689529L 17690540L 17692064L 17689530L 17690541L 17692065L 1768953 lL 17690542L 17692066L 17692070L l 7692193L 17695495L 17698306L 17698457L 17692099L 17692194L 17695519L 17698307L l7698458L 17692101L 17692196L 17695520L 17698308L 17698460L 17692102L 17692197L 17695522L l 7698339L l 7698461L 17692104L 17692205L 17695523L 17698340L 17701761L 17692105L 17692209L 17695524L 17698341L 17701765L 17692107L 17692226L l 7695525L l 7698343L 17701766L 17692109L 17692228L 17695526L 17698344L 17701769L 17692110L 17692229L 17695564L l 7698347L l 7701771L 17692116L 17692230L 17695565L 17698348L 17701773L 17692139L 1769223 lL l7695623L 17698378L 17701774L 17692140L 17692237L l 7695626L 17698382L 17701775L 17692142L l 7692238L 17695628L l 7698383L 17701798L 17692149L 17695427L 17695633L l 7698384L 17701799L 17692150L 17695453L 17697886L 17698385L 17701801L 17692151L 17695455L 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 17701842L
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biosense Webster, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S

Product Codes/Lot Numbers:

l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L l 7689369L 17677144L 17685763L 17689370L 17680082L 17685770L 17689371L 17680149L l 7685772L 17689372L 17680198L 17685795L 17689380L 17680199L l 7685805L 17689381L 17682731L l 7685806L 17689387L 17682732L 17685816L 17689390L 17682733L 17685843L 17689392L 17682789L 17685844L l 7689396L 17682790L l 7685859L 17689403L 17682820L 17685883L 17689405L 17682853L 17685885L 17689413L 17682854L 17685886L 17689444L l 7682855L l 7685887L l 7689445L 17682858L 17685901L 17689447L l 7682910L 17685902L 17689449L l 7682911L l 7689355L l 7689451L 17682912L 17689358L 17689461L 17689462L 17689532L 17690548L 17689477L 17689533L l7690549L 17689479L 17689534L 17690550L l 7689485L l 7689535L l 7690551L 17689486L 17689536L 17692025L 17689487L 17689537L 17692026L 17689488L 17689538L 17692027L 17689489L 17689539L 17692028L 17689490L 17689540L 17692037L 17689491L 17689541L 17692053L 17689492L l7690527L 17692054L 17689493L l 7690528L 17692057L 17689494L 17690529L 17692058L l7689496L 17690530L 17692059L l7689497L 17690531L 17692060L 17689505L 17690533L l 7692061L 17689506L 17690537L 17692062L 17689512L l 7690539L 17692063L l 7689529L 17690540L 17692064L 17689530L 17690541L 17692065L 1768953 lL 17690542L 17692066L 17692070L l 7692193L 17695495L 17698306L 17698457L 17692099L 17692194L 17695519L 17698307L l7698458L 17692101L 17692196L 17695520L 17698308L 17698460L 17692102L 17692197L 17695522L l 7698339L l 7698461L 17692104L 17692205L 17695523L 17698340L 17701761L 17692105L 17692209L 17695524L 17698341L 17701765L 17692107L 17692226L l 7695525L l 7698343L 17701766L 17692109L 17692228L 17695526L 17698344L 17701769L 17692110L 17692229L 17695564L l 7698347L l 7701771L 17692116L 17692230L 17695565L 17698348L 17701773L 17692139L 1769223 lL l7695623L 17698378L 17701774L 17692140L 17692237L l 7695626L 17698382L 17701775L 17692142L l 7692238L 17695628L l 7698383L 17701798L 17692149L 17695427L 17695633L l 7698384L 17701799L 17692150L 17695453L 17697886L 17698385L 17701801L 17692151L 17695455L 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 17701842L

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0055-2018

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