Thermocool Smart Touch Catheter (Uni-Directional and Bi-Directional)… — recall 52271
Health Canada — Medical Devices · Canada · 2014-11-07 · Type II
As described by Health Canada — Medical Devices: Thermocool Smart Touch Catheter (Uni-Directional and Bi-Directional) (2014-10-22)
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Archived by the issuing authority — kept for reference
Reported risk: 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.
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