510(k) · Cleared
Recalled · 2007Medtronic Export XT Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · QEZ Aspiration Thrombectomy Catheter
Cleared on Sep 5, 2006 as substantially equivalent to K040869 (Medtronic Vascular, 2004) after a 56-day review. Its family tree reaches back 3 generations to 2001. 2 of the 38 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010579 (2001). 7 ancestors in all. 30 later devices descend from it, 7 citing it directly. 2 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 2 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 1 generation backK040869 Export CatheterMedtronic Vascular · 2004
- This deviceK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006
- Descendant · cites it directly · 11 of its ownK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- Descendant · cites it directly · 8 of its ownK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K081573Medtronic Export AP CatheterMedtronic Vascular · 2008 · cites it directly11descendants
- K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007 · cites it directly8descendants
- K120808Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012 · cites it directly5descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · cites it directly5descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −2 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −1 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| 0 (this device) | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | — |
| +1 | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| +1 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| +1 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| +1 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +2 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 1 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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.
2 devices in this family have 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040869 | Export CatheterSummary page 5…4143 978.777.0390 [email protected] July 7, 2006 Medtronic® Export® XT Catheter Percutaneous Catheter Percutaneous Catheter Export Aspiration Catheter (K040869) The Medtronic Export XT Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular sit… | 2004 |
What descends from it? (30)
See all 307 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081573 | Medtronic Export AP Catheter | 2008 | 11 |
| K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | 2007 | 8 |
| K120808 | Export XT Catheter, Export AP Catheter | 2012 | 5 |
| K113757 | Aspire Max Aspiration Catheter | 2012 | 5 |
| K131998 | Aspire RX-LP6 Aspiration Catheter | 2013 | 1 |
| K112382 | Terumo Aspriation Catheter | 2011 | 0 |
| K073627 | Flexor Evac Aspiration Catheter | 2008 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2007 | Not classified | Z-0063-2008 | Labeling design | Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K081573 (Medtronic Vascular, 2008) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K040869.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The Medtronic Export® XT Catheter is indicated for:
Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
To subselectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061958: Medtronic Export XT Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061958
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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