Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TactiSys Quartz Pack Recalled by St Jude Medical Due to A configuration update needs to be done on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St Jude Medical directly.
Affected Products
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.
Quantity: 89
Why Was This Recalled?
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St Jude Medical
St Jude Medical has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report