510(k) · Cleared
Recalled · 2010Matrix Stretch Resistant Detachable Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · HCG Device, Neurovascular Embolization
Cleared on May 14, 2003 as substantially equivalent to K012985 (Boston Scientific, Target, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2000. 100 later devices descend from it. It has been recalled 10 times.
- Decided
- May 14, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001083 (2000). 3 ancestors in all. 100 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001083 Guglielmi Detachable Coil and Power Supply, Models Power Supply…Boston Scientific, Target · 2000
- 1 generation backK012985 Matrix Detachable CoilsBoston Scientific, Target · 2002 · Recalled
- This deviceK031168 Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003
- Descendant · cites it directly · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- Descendant · 2 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · cites it directly · 59 of its ownK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- Descendant · 2 generations on · 58 of its ownK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · 3 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · cites it directly66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 2 generations on65descendants
- K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · cites it directly59descendants
- K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010 · 2 generations on58descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4… | Boston Scientific, Target | 2000 | — |
| −1 | K012985 | Matrix Detachable Coils | Boston Scientific, Target | 2002 | 10 |
| 0 (this device) | K031168 | Matrix Stretch Resistant Detachable Coil | Boston Scientific, Target | 2003 | — |
| +1 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +2 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +1 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| +2 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +3 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
Planning a device in HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
What descends from it? (100)
See all 1002 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2010 | Not classified | Z-0855-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0856-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0863-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0860-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0862-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0854-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0857-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0858-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0859-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0861-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K041551 (MicroVention, Inc., 2004) has gone furthest, with 66 descendants of its own.
- 3 other devices also cite its predicate K012985.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
Matrix Detachable Coils are intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable. Matrix Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031168: Matrix Stretch Resistant Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031168
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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