Z-0054-2018Class II

THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

Name: Z-0054-2018 THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Creator: Biosense Webster, Inc.
Published: 2017-09-06
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2017-09-06 / Terminated

FDA source

Biosense Webster, Inc. began a recall of THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S on 2017-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0054-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-06
Posted: 2017-10-27
Terminated: 2019-11-19
Recalling firm: Biosense Webster Inc
Product: THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Product code: LPB Cardiac Ablation Percutaneous Catheter
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 root cause: 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: 357 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
Product codes and lots: 17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0054-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0054-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27
Z-0055-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27
Z-0056-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27
Z-0057-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27
Z-0058-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-27

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)