Devices › Filter, intravascular, cardiovascular
Device brand name · Vena cava filter
Denali Filter: medical device reports filed with FDA
265 reports name it, 2015–2022. Manufacturer given most often on reports: Bard Peripheral Vascular. Product code DTK.
- 265
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.5%
- classified as malfunction
- 29.9% across the product code
- 0.8%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 265 reports that name the brand "Denali Filter" (vena cava filter), received between August 2015 and December 2022; the manufacturer given most often on reports is Bard Peripheral Vascular. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (92.5%), injury (6.8%) and death (0.8%); across all filter, intravascular, cardiovascular reports (product code DTK) death is recorded in 2.4% and malfunction in 29.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to advance (32.5%), malposition of device (20.8%) and patient device interaction problem (19.2%). The patient problems coded most often are injury, pulmonary embolism and death. 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 38,361 reports carrying product code DTK. 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 | 86 | 32.5% | 1.4% |
| Malposition of device | 55 | 20.8% | 10.9% |
| Patient device interaction problem | 51 | 19.2% | 6.4% |
| Difficult to removethe device was hard to remove | 48 | 18.1% | 19.8% |
| Migration or expulsion of device | 33 | 12.5% | 9.6% |
| Detachment of device or device componentpart of the device came off | 32 | 12.1% | 7.8% |
| Material deformation | 16 | 6% | 1.2% |
| Patient-device incompatibilitythe device did not suit the patient | 15 | 5.7% | 4.3% |
| Activation failure | 12 | 4.5% | 1.7% |
| Device dislodged or dislocated | 12 | 4.5% | 0.4% |
| Obstruction of flow | 12 | 4.5% | 4.1% |
| Positioning problem | 12 | 4.5% | 2% |
| Activation, positioning or separation problem | 10 | 3.8% | 1.1% |
| Material puncture/hole | 5 | 1.9% | 0.4% |
| Unintended movement | 4 | 1.5% | 10.2% |
| Bent | 3 | 1.1% | 0.3% |
| Deformation due to compressive stress | 3 | 1.1% | 0.2% |
| Difficult or delayed positioning | 2 | 0.8% | 1.3% |
| Material perforation | 2 | 0.8% | 1% |
| Breakthe device broke | 1 | 0.4% | 1% |
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 |
|---|---|---|
| Injurya physical injury | 5 | 1.9% |
| Pulmonary embolisma blood clot in the lung | 3 | 1.1% |
| Deaththe patient died; cause not stated by this term | 2 | 0.8% |
| Thrombosis | 2 | 0.8% |
| Thrombus | 2 | 0.8% |
| Abdominal painstomach or belly pain | 1 | 0.4% |
| Blood loss | 1 | 0.4% |
| Chest painchest pain | 1 | 0.4% |
| Device embedded in tissue or plaque | 1 | 0.4% |
| Dyspneashortness of breath | 1 | 0.4% |
| Edemaswelling from fluid | 1 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.4% |
| No patient involvement | 1 | 0.4% |
| Occlusion | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Denali Filter | Product code DTK | All MAUDE reports |
|---|---|---|---|
| Reports | 265 | 38,361 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 8 | 24 | 9 |
| Classified as injury | 6.8% | 67% | 36.2% |
| Classified as malfunction | 92.5% | 29.9% | 62.3% |
| Filed by the manufacturer | 99.2% | 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 DTK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gunther Tulip Femoral Vena Cava Filter Set | 1,926 | 0 | 0.6% |
| Gunther Tulip Jugular Vena Cava Filter Set | 1,235 | 0 | 0.7% |
| G2 Filter System - Femoral | 1,122 | 0 | 3.7% |
| Denali Femoral System | 928 | 78 | 4.6% |
| 466fxxxx | 936 | 0 | 1.9% |
| Cook Celect Femoral Vena Cava Filter Set | 898 | 0 | 1.3% |
| Unknown Optease Vena Cava Filter | 835 | 0 | 1.7% |
| Greenfield | 735 | 5 | 0.5% |
| Unknown Trapease | 720 | 0 | 1.7% |
| Denali Jugular System | 704 | 45 | 6.3% |
| Option Ivc Filter | 702 | 0 | 2.1% |
| Trapease Pvcf Fem/Jug 55cm Csi | 983 | 0 | 3.7% |
| Optease Retrieval Filter | 685 | 0 | 3.4% |
| Cook Celect Navalign Femoral Vena Cava Filter Set | 673 | 0 | 1.5% |
| Eclipse Filter System - Femoral | 649 | 0 | 6% |
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 Denali Filter reports
How many FDA reports name Denali Filter?
265 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 (92.5%), injury (6.8%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (32.5%), malposition of device (20.8%), patient device interaction problem (19.2%), difficult to remove (18.1%) and migration or expulsion of device (12.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Denali Filter 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.