Devices › Device, vascular, for promoting embolization
Device brand name · Device vascular for promoting embolization
Interlock-35: medical device reports filed with FDA
626 reports name it, 2018–2025. Manufacturer given most often on reports: Boston Scientific. Product code KRD.
- 626
- device reports naming the brand
- 0% of all MAUDE reports · about 79 a year
- 2
- reports, 12 months to August 2026
- 63 in the 12 months before
- 92.3%
- classified as malfunction
- 74.9% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 626 reports that name the brand "Interlock-35" (device vascular for promoting embolization), received between August 2018 and October 2025; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
2 reports arrived in the 12 months to August 2026, down 97% from 63 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 (92.3%), injury (7.5%) and death (0.2%); across all device, vascular, for promoting embolization reports (product code KRD) death is recorded in 1.6% and malfunction in 74.9%. 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%), entrapment of device (24.8%) and premature activation (20.3%). The patient problems coded most often are pain, complaint, ill-defined 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 14,553 reports carrying product code KRD. 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 | 172 | 27.5% | 6.8% |
| Entrapment of device | 155 | 24.8% | 3.4% |
| Premature activation | 127 | 20.3% | 3.1% |
| Stretched | 104 | 16.6% | 11.1% |
| Physical resistance/sticking | 85 | 13.6% | 9.3% |
| Separation failure | 71 | 11.3% | 18.8% |
| Difficult to removethe device was hard to remove | 70 | 11.2% | 3% |
| Breakthe device broke | 42 | 6.7% | 6.3% |
| Difficult to advance | 27 | 4.3% | 3.3% |
| Material integrity problema problem with the device material | 26 | 4.2% | 0.7% |
| Material protrusion/extrusion | 24 | 3.8% | 1.5% |
| Material deformation | 15 | 2.4% | 3.5% |
| Difficult to insertthe device was hard to insert | 12 | 1.9% | 0.6% |
| Malposition of device | 9 | 1.4% | 1% |
| Detachment of device or device componentpart of the device came off | 8 | 1.3% | 12.6% |
| Migrationthe device moved from where it was placed | 8 | 1.3% | 3.4% |
| Fracturea broken bone | 7 | 1.1% | 0.6% |
| Device-device incompatibility | 4 | 0.6% | 1% |
| Device damaged by another device | 3 | 0.5% | 0.1% |
| Positioning problem | 3 | 0.5% | 1.7% |
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 |
|---|---|---|
| Painpain, site not specified | 7 | 1.1% |
| Complaint, ill-defined | 5 | 0.8% |
| Device embedded in tissue or plaque | 3 | 0.5% |
| Discomfortdiscomfort | 3 | 0.5% |
| Hypersensitivity/allergic reaction | 3 | 0.5% |
| Anxietyanxiety | 2 | 0.3% |
| Chest painchest pain | 2 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.3% |
| Inflammationinflammation | 2 | 0.3% |
| Ischemia | 2 | 0.3% |
| Respiratory distressdifficulty breathing | 2 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Bradycardiaslow heart rate | 1 | 0.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Embolism | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Interlock-35 | Product code KRD | All MAUDE reports |
|---|---|---|---|
| Reports | 626 | 14,553 | 26,136,888 |
| Share of that pool | — | 4.3% | 0% |
| Classified as death, per 1,000 reports | 2 | 16 | 9 |
| Classified as injury | 7.5% | 22.9% | 36.2% |
| Classified as malfunction | 92.3% | 74.9% | 62.3% |
| Filed by the manufacturer | 99.7% | 97.3% | 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 KRD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Axium Prime Brpl 3d | 902 | 135 | 1% |
| Concerto Nylon | 900 | 160 | 2.6% |
| Interlock? | 688 | 37 | 0% |
| Axium Prime Brpl Hlx | 616 | 106 | 1% |
| Interlock?-35 | 542 | 94 | 2.2% |
| Axium 3d | 429 | 48 | 1.6% |
| AZUR CX 35 Detachable | 388 | 58 | 0% |
| Axium Framing Coil | 286 | 57 | 0% |
| Azur CX Detachable | 278 | 38 | 0% |
| Concerto Pgla Hlx | 247 | 54 | 0.8% |
| Axium Helix | 231 | 24 | 3% |
| Retracta Detachable Embolization Coil | 228 | 20 | 0.9% |
| Microvascular Plug | 165 | 11 | 0.6% |
| Axium Prime Bare Pl 3d | 150 | 27 | 0% |
| Concerto | 843 | 199 | 2.7% |
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 Interlock-35 reports
How many FDA reports name Interlock-35?
626 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
malfunction (92.3%), injury (7.5%) and death (0.2%). "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%), entrapment of device (24.8%), premature activation (20.3%), stretched (16.6%) and physical resistance/sticking (13.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Interlock-35 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.