Devices › Device, neurovascular embolization
Device brand name · Hcg krd
Penumbra Coil 400: medical device reports filed with FDA
1,453 reports name it, 2011–2024. Manufacturer given most often on reports: Penumbra. Product code HCG.
- 1,453
- device reports naming the brand
- 0% of all MAUDE reports · about 94 a year
- 0
- reports, 12 months to August 2026
- 1 in the 12 months before
- 78%
- classified as malfunction
- 73% across the product code
- 0.9%
- classified as death, as reported
- 13 reports · not verified by FDA
1,453 medical device reports received by FDA name the brand "Penumbra Coil 400" (hcg krd); the manufacturer given most often on reports is Penumbra; received from February 2011 to September 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 1 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 (78%), injury (20.9%) and death (0.9%); across all device, neurovascular embolization reports (product code HCG) death is recorded in 2.4% and malfunction in 73%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to advance (27.5%), physical resistance (20.6%) and detachment of device component (16.9%). The patient problems coded most often are no patient involvement, thrombus and hemorrhage, subarachnoid. 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 26,252 reports carrying product code HCG. 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 |
|---|---|---|---|
| Failure to advance | 400 | 27.5% | 16.2% |
| Physical resistance | 299 | 20.6% | 7.9% |
| Detachment of device component | 246 | 16.9% | 8.1% |
| Physical resistance/sticking | 174 | 12% | 9.9% |
| Premature separation | 99 | 6.8% | 9.5% |
| Kinkedthe tube or line kinked | 82 | 5.6% | 2.8% |
| Separation failure | 81 | 5.6% | 3.8% |
| Difficult to advance | 77 | 5.3% | 1.6% |
| Breakthe device broke | 71 | 4.9% | 5.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 65 | 4.5% | 1.8% |
| Mechanical jam | 51 | 3.5% | 1.2% |
| Difficult to removethe device was hard to remove | 49 | 3.4% | 2% |
| Premature activation | 45 | 3.1% | 5.6% |
| Insufficient device problem information | 42 | 2.9% | 1% |
| Retraction problem | 38 | 2.6% | 1% |
| Stretched | 33 | 2.3% | 7.4% |
| Detachment of device or device componentpart of the device came off | 29 | 2% | 2.6% |
| Material deformation | 26 | 1.8% | 2.8% |
| Sticking | 23 | 1.6% | 1.2% |
| Out-of-box failure | 21 | 1.4% | 0.6% |
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 |
|---|---|---|
| No patient involvement | 37 | 2.5% |
| Thrombus | 33 | 2.3% |
| Hemorrhage, subarachnoid | 30 | 2.1% |
| Device embedded in tissue or plaque | 24 | 1.7% |
| Deaththe patient died; cause not stated by this term | 21 | 1.4% |
| Dysphasia | 21 | 1.4% |
| Rupturethe device burst | 21 | 1.4% |
| Neurological deficit/dysfunction | 19 | 1.3% |
| Weakness | 19 | 1.3% |
| Infarction, cerebral | 18 | 1.2% |
| Stroke/cva | 17 | 1.2% |
| Transient ischemic attack | 13 | 0.9% |
| Foreign body in patientpart of a device left in the patient | 11 | 0.8% |
| Abdominal painstomach or belly pain | 10 | 0.7% |
| Aneurysm | 10 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Penumbra Coil 400 | Product code HCG | All MAUDE reports |
|---|---|---|---|
| Reports | 1,453 | 26,252 | 26,136,888 |
| Share of that pool | — | 5.5% | 0% |
| Classified as death, per 1,000 reports | 9 | 24 | 9 |
| Classified as injury | 20.9% | 24% | 36.2% |
| Classified as malfunction | 78% | 73% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.5% | 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 HCG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ruby Coil | 3,360 | 26 | 0.1% |
| Penumbra Smart Coil | 2,781 | 3 | 0.3% |
| POD Packing Coil | 1,062 | 35 | 0% |
| Trufill Dcs Orbit Mini Complex Fill | 735 | 0 | 1.6% |
| Ruby Coil Lp | 479 | 13 | 0% |
| Pod | 406 | 18 | 0% |
| Trufill Dcs Orbit Detachable Coils Complex | 395 | 0 | 0.8% |
| Deltaplush - Cerecyte Microcoil | 392 | 0 | 0.3% |
| Penumbra Smart Coil Detachment Handle | 317 | 0 | 0% |
| Deltapaq - Cerecyte Microcoil | 295 | 0 | 0% |
| Orbit Galaxy Detachable Coil System | 273 | 0 | 0.4% |
| Optima Coil System | 255 | 55 | 2% |
| Packing Coil LP | 235 | 11 | 0% |
| Xtrasoft Orbit Galaxy Detachable Coil | 235 | 0 | 1.3% |
| Axium 3-D Detachable Coil | 222 | 0 | 0.5% |
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 Penumbra Coil 400 reports
How many FDA reports name Penumbra Coil 400?
1,453 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (78%), injury (20.9%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (27.5%), physical resistance (20.6%), detachment of device component (16.9%), physical resistance/sticking (12%) and premature separation (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Penumbra Coil 400 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.