Devices › Filter, intravascular, cardiovascular
Device brand name · Dtk filter intravascular cardiovascular
Gunther Tulip Navalign Femoral Vena Cava Filter Set: medical device reports filed with FDA
517 reports name it, 2015–2025. Manufacturer given most often on reports: William Cook Europe. Product code DTK.
- 517
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 2
- reports, 12 months to August 2026
- 1 in the 12 months before
- 27.7%
- classified as malfunction
- 29.9% across the product code
- 2.3%
- classified as death, as reported
- 12 reports · not verified by FDA
517 medical device reports received by FDA name the brand "Gunther Tulip Navalign Femoral Vena Cava Filter Set" (dtk filter intravascular cardiovascular); the manufacturer given most often on reports is William Cook Europe; received from March 2015 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2 reports arrived in the 12 months to August 2026, up 100% from 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 injury (69.6%), malfunction (27.7%) and death (2.3%); 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 insufficient device problem information (53.2%), structural problem (31.1%) and difficult to remove (28.2%). The patient problems coded most often are perforation of vessels, internal organ perforation and pain. 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 |
|---|---|---|---|
| Insufficient device problem information | 275 | 53.2% | 23.2% |
| Structural problem | 161 | 31.1% | 13.4% |
| Difficult to removethe device was hard to remove | 146 | 28.2% | 19.8% |
| Device tipped over | 89 | 17.2% | 6.9% |
| Unintended movement | 53 | 10.3% | 10.2% |
| Obstruction of flow | 34 | 6.6% | 4.1% |
| Malposition of device | 29 | 5.6% | 10.9% |
| Migration or expulsion of device | 25 | 4.8% | 9.6% |
| Fracturea broken bone | 15 | 2.9% | 7.3% |
| Inadequate filtration process | 15 | 2.9% | 1% |
| Entrapment of device | 10 | 1.9% | 1.4% |
| Patient device interaction problem | 10 | 1.9% | 6.4% |
| Detachment of device or device componentpart of the device came off | 9 | 1.7% | 7.8% |
| Activation failure | 8 | 1.5% | 1.7% |
| Migrationthe device moved from where it was placed | 8 | 1.5% | 3.1% |
| Improper or incorrect procedure or method | 4 | 0.8% | 0.4% |
| Difficult or delayed activation | 3 | 0.6% | 0.3% |
| Difficult to advance | 3 | 0.6% | 0.3% |
| Difficult to insertthe device was hard to insert | 3 | 0.6% | 0.5% |
| Sharp edges | 3 | 0.6% | 0% |
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 |
|---|---|---|
| Perforation of vessels | 267 | 51.6% |
| Internal organ perforation | 128 | 24.8% |
| Painpain, site not specified | 118 | 22.8% |
| Anxietyanxiety | 95 | 18.4% |
| Vessel or plaque, device embedded in | 58 | 11.2% |
| Thrombosis | 57 | 11% |
| Pulmonary embolisma blood clot in the lung | 47 | 9.1% |
| Depressionlow mood | 32 | 6.2% |
| Dyspneashortness of breath | 26 | 5% |
| Occlusion | 21 | 4.1% |
| Injurya physical injury | 20 | 3.9% |
| Chest painchest pain | 18 | 3.5% |
| Thrombosis/thrombus | 16 | 3.1% |
| Abdominal painstomach or belly pain | 15 | 2.9% |
| Swellingswelling | 13 | 2.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gunther Tulip Navalign Femoral Vena Cava Filter Set | Product code DTK | All MAUDE reports |
|---|---|---|---|
| Reports | 517 | 38,361 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 23 | 24 | 9 |
| Classified as injury | 69.6% | 67% | 36.2% |
| Classified as malfunction | 27.7% | 29.9% | 62.3% |
| Filed by the manufacturer | 94.8% | 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 Gunther Tulip Navalign Femoral Vena Cava Filter Set reports
How many FDA reports name Gunther Tulip Navalign Femoral Vena Cava Filter Set?
517 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?
injury (69.6%), malfunction (27.7%) and death (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (53.2%), structural problem (31.1%), difficult to remove (28.2%), device tipped over (17.2%) and unintended movement (10.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.8%) and distributor reports (5.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gunther Tulip Navalign Femoral Vena Cava Filter Set 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.