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TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of ...

FDA Recall #Z-1284-2015 — Class II — November 25, 2014

Recall #Z-1284-2015 Date: November 25, 2014 Classification: Class II Status: Terminated

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.

Recalling Firm

St Jude Medical — Saint Paul, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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