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
- Recall Number
- Z-1284-2015
- Event Number
- 70490
- FEI Number
- 3007562768
- Product Code
- OAE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 25, 2014
- Posted
- March 17, 2015
- Terminated
- May 6, 2015
- Address
- St Jude Medical 1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789
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.
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
St. Jude Medical sent a Service Bulletin to inform of a TactiSys Configuration File update that needs to be performed. A technical service personnel will visit each consignee and performed the software change on-site. For questions about this Service Bulletin, contact Technical Support ([email protected]).
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.
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