Devices › Catheter, thrombus retriever
Device brand name · Catheter thrombus retriever
Solitaire Fr: medical device reports filed with FDA
527 reports name it, 2012–2026. Manufacturer given most often on reports: Micro Therapeutics Ev3. Product code NRY.
- 527
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 93
- reports, 12 months to August 2026
- 140 in the 12 months before
- 56.2%
- classified as malfunction
- 49.1% across the product code
- 12.3%
- classified as death, as reported
- 65 reports · not verified by FDA
527 medical device reports received by FDA name the brand "Solitaire Fr" (catheter thrombus retriever); the manufacturer given most often on reports is Micro Therapeutics Ev3; received from April 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
93 reports arrived in the 12 months to August 2026, down 34% from 140 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (56.2%), injury (31.5%) and death (12.3%); across all catheter, thrombus retriever reports (product code NRY) death is recorded in 10.4% and malfunction in 49.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are physical resistance/sticking (41.7%), break (22.6%) and material deformation (20.3%). The patient problems coded most often are intracranial hemorrhage, foreign body in patient and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,663 reports carrying product code NRY. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Physical resistance/sticking | 220 | 41.7% | 10.8% |
| Breakthe device broke | 119 | 22.6% | 16.4% |
| Material deformation | 107 | 20.3% | 6.5% |
| Detachment of device component | 36 | 6.8% | 1.4% |
| Material separation | 25 | 4.7% | 2.5% |
| Separation failure | 19 | 3.6% | 0.3% |
| Retraction problem | 15 | 2.8% | 2% |
| Detachment of device or device componentpart of the device came off | 13 | 2.5% | 0.9% |
| Packaging problem | 8 | 1.5% | 0.2% |
| Insufficient device problem information | 6 | 1.1% | 4.5% |
| Activation failure | 5 | 0.9% | 0.2% |
| Component falling | 4 | 0.8% | 0.1% |
| Difficult to removethe device was hard to remove | 4 | 0.8% | 3.3% |
| Fracturea broken bone | 4 | 0.8% | 8.8% |
| Improper or incorrect procedure or method | 4 | 0.8% | 0.5% |
| Physical resistance | 4 | 0.8% | 2.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.6% | 2.1% |
| Entrapment of device | 3 | 0.6% | 0.5% |
| Device dislodged or dislocated | 2 | 0.4% | 0% |
| Bent | 1 | 0.2% | 0.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Intracranial hemorrhage | 60 | 11.4% |
| Foreign body in patientpart of a device left in the patient | 31 | 5.9% |
| Device embedded in tissue or plaque | 28 | 5.3% |
| Deaththe patient died; cause not stated by this term | 26 | 4.9% |
| Hemorrhage/blood loss/bleeding | 14 | 2.7% |
| Ischemia stroke | 13 | 2.5% |
| Thromboembolism | 13 | 2.5% |
| Hemorrhage, subarachnoid | 11 | 2.1% |
| Infarction, cerebral | 10 | 1.9% |
| Thrombosis/thrombus | 9 | 1.7% |
| Vascular dissection | 9 | 1.7% |
| Stenosis | 8 | 1.5% |
| Obstruction/occlusion | 7 | 1.3% |
| Thrombus | 7 | 1.3% |
| Neurological deficit/dysfunction | 6 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Solitaire Fr | Product code NRY | All MAUDE reports |
|---|---|---|---|
| Reports | 527 | 8,663 | 26,136,888 |
| Share of that pool | — | 6.1% | 0% |
| Classified as death, per 1,000 reports | 123 | 104 | 9 |
| Classified as injury | 31.5% | 40.1% | 36.2% |
| Classified as malfunction | 56.2% | 49.1% | 62.3% |
| Filed by the manufacturer | 99.8% | 97.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NRY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Solitaire Fr4 | 590 | 49 | 13.9% |
| Penumbra System 3max Reperfusion Catheter | 480 | 0 | 3.1% |
| Penumbra System Jet7 Reperfusion Catheter | 379 | 0 | 4% |
| Penumbra System 5max Ace Reperfusion Catheter | 343 | 0 | 0.9% |
| Unknown Solitaire | 310 | 29 | 37.1% |
| Penumbra System Ace 68 Reperfusion Catheter | 208 | 0 | 0% |
| Penumbra System Reperfusion Catheter 032 | 184 | 0 | 9.2% |
| Penumbra System RED 72 Reperfusion Catheter | 158 | 18 | 4.4% |
| Unknown_Neurovascular_Product | 1,062 | 48 | 12.9% |
| Neuron Delivery Catheter 070 | 293 | 0 | 0% |
| Cerenovus Enterprise | 1,543 | 951 | 0.5% |
| Pipeline Flex W/Shield Technology | 3,294 | 922 | 2.2% |
| Px Slim Delivery Microcatheter | 304 | 0 | 0.7% |
| Ruby Coil Detachment Handle | 175 | 0 | 0% |
| Velocity Delivery Microcatheter | 336 | 21 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Solitaire Fr reports
How many FDA reports name Solitaire Fr?
527 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 93 in the latest 12 months.
What kinds of events are reported?
malfunction (56.2%), injury (31.5%) and death (12.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (41.7%), break (22.6%), material deformation (20.3%), detachment of device component (6.8%) and material separation (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Solitaire Fr was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.