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U.S. Department of Health and Human Services

Class 2 Device Recall TactiSys Quartz Pack, PN004 400

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  Class 2 Device Recall TactiSys Quartz Pack, PN004 400 see related information
Date Initiated by Firm November 25, 2014
Date Posted March 17, 2015
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-1284-2015
Recall Event ID 70490
PMA Number P130026 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
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.
Code Information 30078, 30118, 30368, 30059, 30098, 30169, 30110, 30042, 30108, 30066, 30067, 30117, 30172, 30063, 30061, 30060, 30161, 30183, 30129, 30097, 30341, 30043, 30344, 30139, 30112, 30148, 30071, 30096, 30221, 30178, 30204, 30076, 30332, 30343, 30056, 30082, 30123, 30091, 30054, 30087, 30218, 30173, 30143, 30095, 30157, 30176, 30068, 30152, 30158, 30080, 30083, 30153, 30093, 30452, 30121, 30160, 30165, 30088, 30180, 30195, 40000, 30109, 30090, 30147, 30156, 30174, 30124, 30058, 30105, 30070, 30170, 30084, 30333, 30089, 30350, 30222, 30228, 30229, 30134, 30045, 30346, 30177, 30184, 30454, 30111, 30075, 30073, 30219, 30085.
Recalling Firm/
Manufacturer		 St Jude Medical
1 Saint Jude Medical Dr
Saint Paul MN 55117-1789
Manufacturer Reason
for Recall		 A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
FDA Determined
Cause 2		 Software design
Action 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 (ETechsupport@sjm.com).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAE and Original Applicant = St. Jude Medical
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