FDA Device recall Z-0055-2018

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

FDA Device
Class II
terminated
Published 2017-11-08

On 2017-11-08 the FDA classified a Class II recall of THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S by Biosense Webster, citing 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 cathe….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0055-2018
Classification	Class II
Status	terminated
Initiated	2017-09-06
Published	2017-11-08
Last updated	2026-09-13 11:54 UTC
Company	Biosense Webster
Distribution	n/a

Product

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

Reason

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.

Identifiers

code_info	l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L l 7689369L 17677144L 17685763L 17… 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

code_info

l 7673851L l 7685693L 17689360L 17676952L 17685715L l 7689361L 17677062L 17685742L l 7689369L 17677144L 17685763L 17…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0055-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.