Devices › Catheter, embolectomy
Device brand name · Catheter embolectomy
Angiojet Zelantedvt: medical device reports filed with FDA
304 reports name it, 2015–2021. Manufacturer given most often on reports: Boston Scientific - Maple Grove. Product code DXE.
- 304
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 76.3%
- classified as malfunction
- 80.1% across the product code
- 5.3%
- classified as death, as reported
- 16 reports · not verified by FDA
304 medical device reports received by FDA name the brand "Angiojet Zelantedvt" (catheter embolectomy); the manufacturer given most often on reports is Boston Scientific - Maple Grove; received from September 2015 to December 2021. 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, 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 (76.3%), injury (18.4%) and death (5.3%); 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 aspiration issue (32.6%), device displays incorrect message (31.3%) and entrapment of device (15.8%). The patient problems coded most often are renal failure, death and bradycardia. 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 |
|---|---|---|---|
| Aspiration issue | 99 | 32.6% | 6.4% |
| Device displays incorrect message | 95 | 31.3% | 5.8% |
| Entrapment of device | 48 | 15.8% | 1.7% |
| Breakthe device broke | 22 | 7.2% | 12.7% |
| Leak/splashthe device leaked | 15 | 4.9% | 2.6% |
| Display or visual feedback problem | 14 | 4.6% | 1.6% |
| Detachment of device or device componentpart of the device came off | 8 | 2.6% | 3.8% |
| Difficult to removethe device was hard to remove | 8 | 2.6% | 2.6% |
| Device difficult to setup or prepare | 6 | 2% | 0.6% |
| Difficult to advance | 5 | 1.6% | 0.5% |
| Failure to prime | 5 | 1.6% | 0.8% |
| Suction problem | 5 | 1.6% | 2.1% |
| Defective devicethe device was defective | 4 | 1.3% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1% | 1.3% |
| Fracturea broken bone | 2 | 0.7% | 1.3% |
| Material deformation | 2 | 0.7% | 6% |
| Material integrity problema problem with the device material | 2 | 0.7% | 0.3% |
| Pumping problem | 2 | 0.7% | 0.3% |
| Unsealed device packaging | 2 | 0.7% | 0.1% |
| Contamination | 1 | 0.3% | 0.2% |
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 |
|---|---|---|
| Renal failurekidney failure | 25 | 8.2% |
| Deaththe patient died; cause not stated by this term | 15 | 4.9% |
| Bradycardiaslow heart rate | 13 | 4.3% |
| No patient involvement | 13 | 4.3% |
| Hemolysis | 10 | 3.3% |
| Pulmonary embolisma blood clot in the lung | 10 | 3.3% |
| Low blood pressure/ hypotension | 8 | 2.6% |
| Tachycardiafast heart rate | 6 | 2% |
| Cardiac arrestthe heart stopped | 5 | 1.6% |
| Dyspneashortness of breath | 4 | 1.3% |
| Cardiopulmonary arrest | 3 | 1% |
| High blood pressure/ hypertension | 3 | 1% |
| Chest painchest pain | 2 | 0.7% |
| Embolism | 2 | 0.7% |
| Hemorrhage/blood loss/bleeding | 2 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Angiojet Zelantedvt | Product code DXE | All MAUDE reports |
|---|---|---|---|
| Reports | 304 | 7,789 | 26,136,888 |
| Share of that pool | — | 3.9% | 0% |
| Classified as death, per 1,000 reports | 53 | 18 | 9 |
| Classified as injury | 18.4% | 14.4% | 36.2% |
| Classified as malfunction | 76.3% | 80.1% | 62.3% |
| Filed by the manufacturer | 97.7% | 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% |
| Indigo System Aspiration Catheter 8 | 196 | 2 | 1.5% |
| Indigo System Separator 8 | 157 | 4 | 1.9% |
| 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 Angiojet Zelantedvt reports
How many FDA reports name Angiojet Zelantedvt?
304 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 (76.3%), injury (18.4%) and death (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
aspiration issue (32.6%), device displays incorrect message (31.3%), entrapment of device (15.8%), break (7.2%) and leak/splash (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Angiojet Zelantedvt 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.