# P130026: Tacticath Quartz Set

- Pathway: PMA
- Applicant: St Jude Medical
- Decided: Oct 24, 2014 after 329 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 18, 2023 · Class II · Z-0814-2024: When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. Th
- Mar 24, 2022 · Class II · Z-0956-2022: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
- Mar 24, 2022 · Class II · Z-0957-2022: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
- May 22, 2020 · Class II · Z-2541-2020: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
- Apr 5, 2019 · Class II · Z-1493-2019: In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to inte
- Nov 25, 2014 · Class II · Z-1284-2015: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

Source page: https://510kreport.com/device/P130026
Methodology: https://510kreport.com/methodology