# P220013: TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: May 18, 2023 after 276 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 5 (5 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.
1 of 1 device in its family (counting itself) has 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
- Sep 10, 2025 · Class I · Z-0109-2026: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Sep 10, 2025 · Class I · Z-0113-2026: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Sep 10, 2025 · Class I · Z-0111-2026: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Sep 10, 2025 · Class I · Z-0112-2026: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Sep 10, 2025 · Class I · Z-0110-2026: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Source page: https://510kreport.com/device/P220013
Methodology: https://510kreport.com/methodology