510(k) · Cleared
Recalled · Class II · 2014Modification to Merci Retriever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Aug 15, 2008 as substantially equivalent to K081305 (Concentric Medical, Inc., 2008) after a 29-day review. Its family tree reaches back 2 generations to 2007. 1 of the 27 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071172 (2007). 24 later devices descend from it, 2 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK071172 Modified Merci Retriever, Model 90060Concentric Medical, Inc. · 2007
- 1 generation backK081305 Merci RetrieverConcentric Medical, Inc. · 2008
- This deviceK082034 Modification to Merci RetrieverConcentric Medical, Inc. · 2008
- Descendant · cites it directly · 23 of its ownK090085 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111…Concentric Medical, Inc. · 2009
- Descendant · cites it directly · 22 of its ownK113455 Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 2 generations on · 18 of its ownK123378 Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012
- Descendant · 2 generations on · 17 of its ownK141491 Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- Descendant · 2 generations on · 10 of its ownK153071 Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141516 Mindframe Capture LP Revascularization Device2 generations on · 2015
Most influential descendants
Showing 5 of 24 · See all- K090085Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Concentric Medical, Inc. · 2009 · cites it directly23descendants
- K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · cites it directly22descendants
- K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular · 2012 · 2 generations on18descendants
- K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · 2 generations on17descendants
- K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071172 | Modified Merci Retriever, Model 90060 | Concentric Medical, Inc. | 2007 | — |
| −1 | K081305 | Merci Retriever | Concentric Medical, Inc. | 2008 | — |
| 0 (this device) | K082034 | Modification to Merci Retriever | Concentric Medical, Inc. | 2008 | — |
| +1 | K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 | Concentric Medical, Inc. | 2009 | — |
| +1 | K113455 | Solitaire FR Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +2 | K123378 | Solitaire 2 Revascularization Device | Micro Therapeutics Dba Ev3 Neurovascular | 2012 | — |
| +2 | K141491 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| +2 | K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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.
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 NRY device
- #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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 |
|---|---|---|---|
| * | K081305 | Merci RetrieverSummary page 1…trieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. Predicate Device Merci® Retriever, K081305 Device Description Like the predicate device, the design of the modified Merci Retriever consists of a flexible, tapered Nitino… | 2008 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2014 | Class II | Z-2598-2014 | Process control | Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date. |
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.
- K141516Mindframe Capture LP Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090085 (Concentric Medical, Inc., 2009) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K081305.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, 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 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IVt-PA) or who fail IVt-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082034: Modification to Merci Retriever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082034
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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