THERMOCOOL SMARTTOUCH SF UNI-/BI-DIRECTIONAL NAVIGATION CATHETER (2017-09-11)

Starting date:

September 11, 2017

Posting date:

September 26, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-64604

• 
  Reason
• 
  Affected products

Affected products

1. THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
2. THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

Reason

Biosense Webster has 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 magnetic distortion which may result in inaccurate catheter tip location information. This may lead the physician to ablate in an unintended area when delivering RF energy. The user manual provides steps for resolving this alert but for the lots subject to this recall, those steps are not effective. Subject lots are therefore being removed.

Affected products