Devices › Catheter, electrode recording, or probe, electrode recording
Device brand name · Catheter electrode recording or probe electrode recording
IntellaMap Orion: medical device reports filed with FDA
261 reports name it, 2014–2026. Manufacturer given most often on reports: Boston Scientific - Costa Rica Heredia. Product code DRF.
- 261
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 52
- reports, 12 months to August 2026
- 23 in the 12 months before
- 54.8%
- classified as malfunction
- 48.8% across the product code
- 0.8%
- classified as death, as reported
- 2 reports · not verified by FDA
261 medical device reports received by FDA name the brand "IntellaMap Orion" (catheter electrode recording or probe electrode recording); the manufacturer given most often on reports is Boston Scientific - Costa Rica Heredia; received from November 2014 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
52 reports arrived in the 12 months to August 2026, up 126% from 23 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 (54.8%), injury (44.4%) and death (0.8%); across all catheter, electrode recording, or probe, electrode recording reports (product code DRF) death is recorded in 3.5% and malfunction in 48.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device sensing problem (6.5%), difficult to remove (6.5%) and device contamination with chemical or other material (5.7%). The patient problems coded most often are pericardial effusion, cardiac tamponade and low blood pressure/ hypotension. 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 8,781 reports carrying product code DRF. 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 |
|---|---|---|---|
| Device sensing problem | 17 | 6.5% | 0.5% |
| Difficult to removethe device was hard to remove | 17 | 6.5% | 3.4% |
| Device contamination with chemical or other material | 15 | 5.7% | 1.5% |
| Breakthe device broke | 13 | 5% | 3% |
| Failure to sense | 12 | 4.6% | 0.8% |
| Material integrity problema problem with the device material | 10 | 3.8% | 2.3% |
| Activation, positioning or separation problem | 6 | 2.3% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 2.3% | 2.1% |
| Deformation due to compressive stress | 5 | 1.9% | 0.1% |
| Entrapment of device | 5 | 1.9% | 3.6% |
| Fracturea broken bone | 5 | 1.9% | 1.7% |
| Material perforation | 5 | 1.9% | 0.4% |
| Nonstandard device | 4 | 1.5% | 0.1% |
| Activation problem | 3 | 1.1% | 0% |
| Contamination | 3 | 1.1% | 0.2% |
| Detachment of device component | 3 | 1.1% | 0.9% |
| Detachment of device or device componentpart of the device came off | 3 | 1.1% | 1.1% |
| Display or visual feedback problem | 3 | 1.1% | 0.6% |
| Positioning problem | 3 | 1.1% | 1% |
| Defective component | 2 | 0.8% | 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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 35 | 13.4% |
| Cardiac tamponade | 32 | 12.3% |
| Low blood pressure/ hypotension | 21 | 8% |
| Cardiac perforation | 12 | 4.6% |
| Stroke/cva | 9 | 3.4% |
| Air embolism | 5 | 1.9% |
| Arrhythmia | 5 | 1.9% |
| Thrombus | 5 | 1.9% |
| Tissue damage | 5 | 1.9% |
| Cardiac arrestthe heart stopped | 4 | 1.5% |
| Non specific ekg/ECG changes | 4 | 1.5% |
| Thrombosis | 4 | 1.5% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 4 | 1.5% |
| Embolism | 3 | 1.1% |
| Ischemia stroke | 3 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | IntellaMap Orion | Product code DRF | All MAUDE reports |
|---|---|---|---|
| Reports | 261 | 8,781 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 8 | 35 | 9 |
| Classified as injury | 44.4% | 47.1% | 36.2% |
| Classified as malfunction | 54.8% | 48.8% | 62.3% |
| Filed by the manufacturer | 100% | 94.8% | 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 DRF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Achieve Mapping Catheter - 20 mm | 1,171 | 82 | 3.1% |
| Achieve Mapping Catheter | 645 | 0 | 4.7% |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | 480 | 32 | 3.3% |
| Intellamap Orion High Resolution Mapping Catheter | 386 | 0 | 4.1% |
| Achieve Advance Mapping Catheter | 361 | 34 | 4.4% |
| Lasso 2515 Nav Eco Variable Catheter | 231 | 0 | 0.4% |
| Inquiry Steerable Diagnostic Catheter | 233 | 8 | 3.9% |
| Stockert 70 Rf Generator | 212 | 0 | 4.2% |
| Lasso 2515 Nav Variable Catheter | 188 | 0 | 0.5% |
| Navistar Electrophysiology Catheter | 184 | 0 | 6% |
| Decanav Electrophysiology Catheter | 153 | 4 | 3.3% |
| NaviStar ThermoCool | 673 | 20 | 7% |
| Polarsheath | 418 | 12 | 1.2% |
| Viking | 181 | 1 | 5% |
| QDOT Micro | 1,169 | 390 | 3% |
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 IntellaMap Orion reports
How many FDA reports name IntellaMap Orion?
261 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 52 in the latest 12 months.
What kinds of events are reported?
malfunction (54.8%), injury (44.4%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (6.5%), difficult to remove (6.5%), device contamination with chemical or other material (5.7%), break (5%) and failure to sense (4.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that IntellaMap Orion 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.