Product Wiki · Recalls · Health Canada — Medical Devices

THERMOCOOL SMARTTOUCH SF UNI-/BI-DIRECTIONAL NAVIGATION CATHETER… — recall 57089

Health Canada — Medical Devices · Canada · 2017-09-26 · Type II

As described by Health Canada — Medical Devices: THERMOCOOL SMARTTOUCH SF UNI-/BI-DIRECTIONAL NAVIGATION CATHETER (2017-09-11)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
57089
Date of alert
2017-09-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/thermocool-smarttouch-sf-uni-b

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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