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  Class 2 Device Recall THERMOCOOL SMARTTOUCH see related information
Date Initiated by Firm September 06, 2017
Create Date October 27, 2017
Recall Status1 Terminated 3 on November 19, 2019
Recall Number Z-0055-2018
Recall Event ID 78129
PMA Number P030031S072 
Product Classification Cardiac ablation percutaneous catheter - Product Code LPB
Product THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Code Information 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 
Recalling Firm/
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Biosense Webster sales representative
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS customer communication will occur in accordance with local regulations.
Quantity in Commerce 1962 units
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPB and Original Applicant = BIOSENSE WEBSTER, INC.