# P220032: POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Aug 8, 2023 after 231 days
- Product code: OAE (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: 7 (7 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
- Oct 10, 2024 · Class I · Z-0299-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0302-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0297-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0298-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0300-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0301-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Oct 10, 2024 · Class I · Z-0303-2025: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Source page: https://510kreport.com/device/P220032
Methodology: https://510kreport.com/methodology