510(k) · Cleared
Recalled · Class II · 2022Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXE Catheter, Embolectomy
Cleared on Jun 12, 2020 after a 190-day review. The FDA summary names no predicate by number. It has been recalled 2 times.
- Decided
- Jun 12, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 2
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2022 | Class II | Z-0147-2023 | Packaging | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| Oct 6, 2022 | Class II | Z-0146-2023 | Packaging | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Fogarty Arterial Embolectomy Catheter:
The Fogarty Arterial Embolectomy Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.
Fogarty Biliary Balloon Probe:
The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193379: Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193379
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026