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St Jude Medical recalls TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythm
Recalled March 25, 2015 · FDA recall Z-1284-2015 · St Jude Medical
Hazard
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. · FDA Class II
Units
89
Sold at
US Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL IN, KS, LA, MD, MA, MI, MN,MS, NE, NV,NH, NM, NY, NC, OH, OK OR, PA, TN, TX, UT, VA,WA.
Description
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
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.
Manufacturer(s)
St Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →