Events

Field Safety Notices about THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheters and THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Biosense Webster Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here

Type of Event
Field Safety Notice
Event ID
6.6.4-2017-68375
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Engangsprodukter--THERMOCOOL-SMARTTOUCH--och-THERMOCOOL-SF-NAV-katetrar--Biosense-Webster-Inc/#
Notes / Alerts

Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Sweden.
Extra notes in the data

950445
Action
Products should be revoked.

Device

THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH SF Bi-Directi...

Model / Serial
Product Description
Disposable products
Manufacturer
Biosense Webster Inc.

Manufacturer

Biosense Webster Inc.

Manufacturer Parent Company (2017)
Johnson & Johnson
Source
SMPA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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