Recall Z-1284-2015— St Jude Medical
Class II · Terminated
Class II FDA medical device recall by St Jude Medical, initiated 2014-11-25, terminated 2015-05-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters..
- Recalling firm
- St Jude Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-25
- Terminated
- 2015-05-06
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.