510(k) · Cleared
Recalled · Class I · 2016Fetch 2 Aspiration Catheter Model 109400-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad Interventional/Possis · QEZ Aspiration Thrombectomy Catheter
Cleared on Jan 21, 2011 as substantially equivalent to K081989 (Possis Medical, Inc., 2008) after a 252-day review. Its family tree reaches back 5 generations to 2003. 1 of the 8 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jan 21, 2011
- Review
- 252 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032763 (2003). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
- 4 generations backK042937 Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005
- 3 generations backK062172 Fetch Aspiration CatheterPossis Medical, Inc. · 2006
- 2 generations backK070363 Fetch Aspiration CatheterPossis Medical, Inc. · 2007
- 1 generation backK081989 Modification to Fetch Aspiration CatheterPossis Medical, Inc. · 2008
- This deviceK101354 Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032763 | Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2003 | 1 |
| −4 | K042937 | Modification to Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −3 | K062172 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2006 | — |
| −2 | K070363 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2007 | — |
| −1 | K081989 | Modification to Fetch Aspiration Catheter | Possis Medical, Inc. | 2008 | — |
| 0 (this device) | K101354 | Fetch 2 Aspiration Catheter Model 109400-001 | Medrad Interventional/Possis | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 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.
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 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 |
|---|---|---|---|
| * | K081989 | Modification to Fetch Aspiration CatheterSummary page 5…s.com Date Submitted: May 13, 2010 Trade Name: Fetch® 2 Aspiration Catheter Classification: 870.5150 Product Code: DXE Predicate Device(s): Fetch Aspiration catheter: K081989 MEDRAD Interventional / Possis 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433-8003 Device Description: The Fetch 2 Aspirati… | 2008 |
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 |
|---|---|---|---|---|
| Mar 22, 2016 | Class I | Z-1342-2016 | Process control | Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
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/K101354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101354: Fetch 2 Aspiration Catheter Model 109400-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101354
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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