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Terminated

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.

FDA Recall Z-1284-2015 · Posted 2015-03-17

Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeOAE
Date Initiated2014-11-25
Date Terminated2015-05-06
Product Quantity89

Reason for Recall

A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

Firm 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 ([email protected]).

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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