PlainRecalls
FDA Devices Moderate Class II Terminated

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-dimens

Reported: March 25, 2015 Initiated: November 25, 2014 #Z-1284-2015

Product Description

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.

Reason for Recall

A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

Details

Recalling Firm
St Jude Medical
Units Affected
89
Distribution
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.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by St Jude Medical. Units affected: 89.
Why was this product recalled? ▼
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1284-2015.

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