FDA Device recall Z-1284-2015
TactiSys Quartz Pack, PN-004 400
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of TactiSys Quartz Pack, PN-004 400 by St Jude Medical, citing A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1284-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-25 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
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
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Identifiers
| code_info | 30078, 30118, 30368, 30059, 30098, 30169, 30110, 30042, 30108, 30066, 30067, 30117, 30172, 30063, 30061, 30060, 30161,…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1284-2015%22
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