Reported Mar 25, 2015 · Terminated
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias…
St Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical · 1 Saint Jude Medical Dr · Saint Paul, MN · 55117-1789
Is this the product you have?
- 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 UsageThis 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
- Lot codes and dates
89 of 89 codes
300783011830368300593009830169301103004230108300663006730117301723006330061300603016130183301293009730341300433034430139301123014830071300963022130178302043007630332303433005630082301233009130054300873021830173301433009530157301763006830152301583008030083301533009330452301213016030165300883018030195
- Amount recalled
- 89
Where it was sold
Why it was recalled
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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