Company:St Jude Medical.
Date of Enforcement Report: 3/25/2015
Class lI:
PRODUCT
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.
Recall Number Z-1284-2015
REASON
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
RECALLING FIRM/MANUFACTURER
St Jude Medical, Saint Paul, MN on 11/25/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
89
DISTRIBUTION
Nationwide
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