PMA · Approved
Recalled · Class I · 2024POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approved on Aug 8, 2023 through premarket approval, which rests on the device’s own clinical evidence after a 231-day review. It has a Class I recall. It has been recalled 7 times, including 7 Class I recalls.
- Decided
- Aug 8, 2023
- Review
- 231 days
- Class
- Class III
- Product code
- OAE
- Recalls
- 7 (7 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P220032 has 12 supplements since 2023: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2024 | Class I | Z-0299-2025 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OAE devicesOAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OAE
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAE
Too few OAE 510(k)s in any year since 2007 to give a median.
Recalls per year · OAE
5in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · OAE
1,412in 2025
MAUDE reports naming product code OAE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 5 | 0 |
| 2011 | 14 | — | 1 | 69 |
| 2012 | 10 | — | 0 | 70 |
| 2013 | 10 | — | 0 | 111 |
| 2014 | 15 | — | 0 | 131 |
| 2015 | 15 | — | 0 | 274 |
| 2016 | 19 | — | 0 | 311 |
| 2017 | 15 | — | 0 | 387 |
| 2018 | 28 | — | 0 | 884 |
| 2019 | 34 | — | 1 | 908 |
| 2020 | 27 | — | 0 | 744 |
| 2021 | 31 | — | 0 | 914 |
| 2022 | 26 | — | 2 | 1,161 |
| 2023 | 43 | — | 1 | 1,311 |
| 2024 | 32 | — | 7 (7) | 2,098 |
| 2025 | 20 | — | 5 (5) | 1,412 |
| 2026 | 25 | — | 0 | — |
https://510kreport.com/device/P220032 · printed Nov 3, 2026
Cite this page
510(k) Report. “P220032: POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P220032
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026