Thermocool Smart Touch Catheter (Uni-Directional and Bi-Directional) (2014-10-22)

Starting date:

October 22, 2014

Posting date:

November 7, 2014

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-42035

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  Reason
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  Affected products

Recalled Products

A) Thermocool Smart Touch Catheter(Uni-Dir)

B) Thermocool Smart Touch Catheter (Bi-Dir)

Reason

Biosense Webster has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the Thermocool Smart Touch Catheter between January 2012 and July 2014. None of these complaints were associated with adverse events. Manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. The purpose of the field safety notice is to reinforce the warnings and precautions and directions for use in the current IFU, as well as to notify customers of upcoming updates to the IFU's warnings and precautions.

Affected products