Z-1284-2015 Class II Terminated
FDA device recall Z-1284-2015 was initiated by St Jude Medical on Nov 25, 2014 and is designated Class II. Reason for recall: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. The recall status is terminated (terminated May 6, 2015). Affected quantity: 89.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 25, 2015
- Initiation Date
- Nov 25, 2014
- Termination Date
- May 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89
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.
Distribution Pattern
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1284-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026