Devices › Catheter, embolectomy
Device brand name · Dxe
Indigo System Separator 8: medical device reports filed with FDA
157 reports name it, 2015–2025. Manufacturer given most often on reports: Penumbra. Product code DXE.
- 157
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 4
- reports, 12 months to August 2026
- 6 in the 12 months before
- 75.8%
- classified as malfunction
- 80.1% across the product code
- 1.9%
- classified as death, as reported
- 3 reports · not verified by FDA
157 medical device reports received by FDA name the brand "Indigo System Separator 8" (dxe); the manufacturer given most often on reports is Penumbra; received from August 2015 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
4 reports arrived in the 12 months to August 2026, down 33% from 6 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 (75.8%), injury (22.3%) and death (1.9%); across all catheter, embolectomy reports (product code DXE) death is recorded in 1.8% and malfunction in 80.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (46.5%), material separation (14%) and entrapment of device (7%). The patient problems coded most often are device embedded in tissue or plaque, hemoptysis and no patient involvement. 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 7,789 reports carrying product code DXE. 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 |
|---|---|---|---|
| Breakthe device broke | 73 | 46.5% | 12.7% |
| Material separation | 22 | 14% | 5.7% |
| Entrapment of device | 11 | 7% | 1.7% |
| Material deformation | 11 | 7% | 6% |
| Stretched | 11 | 7% | 0.8% |
| Physical resistance | 10 | 6.4% | 1.8% |
| Physical resistance/sticking | 10 | 6.4% | 2.8% |
| Detachment of device component | 8 | 5.1% | 4.9% |
| Fracturea broken bone | 7 | 4.5% | 1.3% |
| Detachment of device or device componentpart of the device came off | 4 | 2.5% | 3.8% |
| Device dislodged or dislocated | 4 | 2.5% | 0.4% |
| Device handling problem | 4 | 2.5% | 0.9% |
| Device slipped | 3 | 1.9% | 0.1% |
| Failure to advance | 3 | 1.9% | 1.8% |
| Bent | 2 | 1.3% | 0.5% |
| Defective devicethe device was defective | 2 | 1.3% | 0.4% |
| Device damaged prior to usethe device was damaged before use | 2 | 1.3% | 2.3% |
| Material integrity problema problem with the device material | 2 | 1.3% | 0.3% |
| Out-of-box failure | 2 | 1.3% | 1% |
| Component missing | 1 | 0.6% | 0.5% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 12 | 7.6% |
| Hemoptysis | 7 | 4.5% |
| No patient involvement | 5 | 3.2% |
| Deaththe patient died; cause not stated by this term | 3 | 1.9% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Chest painchest pain | 1 | 0.6% |
| Extravasation | 1 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Heart failure | 1 | 0.6% |
| Infarction, cerebral | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| Low oxygen saturation | 1 | 0.6% |
| Perforation | 1 | 0.6% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 1 | 0.6% |
| Vomitingbeing sick | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Indigo System Separator 8 | Product code DXE | All MAUDE reports |
|---|---|---|---|
| Reports | 157 | 7,789 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 19 | 18 | 9 |
| Classified as injury | 22.3% | 14.4% | 36.2% |
| Classified as malfunction | 75.8% | 80.1% | 62.3% |
| Filed by the manufacturer | 98.7% | 93% | 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 DXE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fogarty Arterial Embolectomy Catheter | 1,165 | 37 | 0.2% |
| AngioJet SOLENT omni | 671 | 26 | 1.3% |
| Fogarty Thru-Lumen Embolectomy Catheter | 427 | 76 | 0.7% |
| Indigo System Aspiration Catheter 6 | 472 | 0 | 0% |
| TufTex Over-the-Wire Embolectomy Catheter | 361 | 159 | 0% |
| Angiojet Zelantedvt | 304 | 0 | 5.3% |
| Indigo System Aspiration Catheter 8 | 196 | 2 | 1.5% |
| Indigo System Catrx Aspiration Catheter | 259 | 11 | 0% |
| AngioJet SOLENT Proxi | 175 | 5 | 4.6% |
| AdvanCE | 220 | 8 | 2.7% |
| Pruitt F3 Carotid Shunt | 395 | 73 | 0.3% |
| Internal Hex Implant | 2,074 | 0 | 0% |
| Galileo | 701 | 0 | 0.1% |
| Penumbra System Jet7 Reperfusion Catheter | 379 | 0 | 4% |
| Ruby Coil | 3,360 | 26 | 0.1% |
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 Indigo System Separator 8 reports
How many FDA reports name Indigo System Separator 8?
157 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.
What kinds of events are reported?
malfunction (75.8%), injury (22.3%) and death (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (46.5%), material separation (14%), entrapment of device (7%), material deformation (7%) and stretched (7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Indigo System Separator 8 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.