510(k) · Cleared
Recalled · Class I · 2026Over the Wire Embolectomy Catheter, Model 2302
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · DXE Catheter, Embolectomy
Cleared on Jan 14, 2003 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 53 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it. It has been recalled 11 times, including a Class I recall.
- Decided
- Jan 14, 2003
- Review
- 196 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 11 (1 Class I)
- Predicates
- 0
52 later devices descend from it, 1 citing it directly. 1 of the 53 devices in this family, counting this one, has a Class I recall.
- This deviceK022145 Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003
- Descendant · cites it directly · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · cites it directly51descendants
- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 2 generations on35descendants
- K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009 · 2 generations on7descendants
- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 3 generations on6descendants
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022145 | Over the Wire Embolectomy Catheter, Model 2302 | LeMaitre Vascular, Inc. | 2003 | — |
| +1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| +2 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +2 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| +3 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
| +3 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)… | 2004 | 51 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2026 | Class II | Z-0117-2027 | Under Investigation by firm | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
| Apr 11, 2025 | Class II | Z-1750-2025 | Packaging process control | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Mar 23, 2020 | Class I | Z-1567-2020 | Process control | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. |
| Oct 21, 2015 | Class II | Z-0378-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0379-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0383-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0380-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0381-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0382-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0384-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Oct 21, 2015 | Class II | Z-0385-2016 | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040010 (Genesis Medical Interventional, Inc., 2004) has gone furthest, with 51 descendants of its own.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K022145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022145: Over the Wire Embolectomy Catheter, Model 2302.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022145
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026