PMA · Approved
Recalled · Class I · 2025Pipeline Embolization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · OUT Intracranial Aneurysm Flow Diverter
Approved on Apr 6, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 323-day review. It has a Class I recall. It has been recalled 12 times, including 10 Class I recalls.
- Decided
- Apr 6, 2011
- Review
- 323 days
- Class
- Class III
- Product code
- OUT
- Recalls
- 12 (10 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100018 has 51 supplements since 2011: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 6 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 4 |
Sources: FDA PMA database (decision fields and supplements), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Jan 30, 2025 | Class I | Z-1245-2025 | Device Design | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically… |
| Jan 30, 2025 | Class I | Z-1246-2025 | Device Design | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically… |
| Jul 13, 2021 | Class I | Z-2402-2021 | Device Design | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. |
| Jul 13, 2021 | Class I | Z-2403-2021 | Device Design | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. |
| Feb 14, 2020 | Class I | Z-1527-2020 | Process change control | Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a… |
| Oct 5, 2016 | Class I | Z-0307-2017 | Device Design | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. |
| Oct 5, 2016 | Class I | Z-0308-2017 | Device Design | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. |
| Oct 5, 2016 | Class I | Z-0309-2017 | Device Design | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. |
| Oct 5, 2016 | Class I | Z-0310-2017 | Device Design | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. |
| Sep 4, 2015 | Class II | Z-0120-2016 | Process control | The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use. |
| Apr 1, 2014 | Class I | Z-1453-2014 | Process change control | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. |
| Jul 19, 2013 | Class II | Z-2045-2013 | Employee error | Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OUT devicesOUT Intracranial Aneurysm Flow Diverter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OUT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUT
Too few OUT 510(k)s in any year since 2007 to give a median.
Recalls per year · OUT
3so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OUT
1,625in 2025
MAUDE reports naming product code OUT, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 335 |
| 2013 | 4 | — | 0 | 618 |
| 2014 | 3 | — | 0 | 438 |
| 2015 | 1 | — | 1 | 562 |
| 2016 | 1 | — | 1 (1) | 540 |
| 2017 | 1 | — | 0 | 448 |
| 2018 | 7 | — | 0 | 425 |
| 2019 | 5 | — | 0 | 528 |
| 2020 | 9 | — | 0 | 809 |
| 2021 | 13 | — | 0 | 850 |
| 2022 | 7 | — | 0 | 1,118 |
| 2023 | 8 | — | 0 | 1,186 |
| 2024 | 14 | — | 0 | 1,326 |
| 2025 | 10 | — | 1 | 1,625 |
| 2026 | 6 | — | 3 | — |
https://510kreport.com/device/P100018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100018: Pipeline Embolization Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100018
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026