Devices › Transducer, pressure, catheter tip
Device brand name · Transducer pressure catheter tip
PressureWire: medical device reports filed with FDA
169 reports name it, 2013–2026. Manufacturer given most often on reports: Lightlab Imaging. Product code DXO.
- 169
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 80
- reports, 12 months to August 2026
- 50 in the 12 months before
- 70.4%
- classified as malfunction
- 81% across the product code
- 1.8%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 169 reports that name the brand "PressureWire" (transducer pressure catheter tip), received between August 2013 and August 2026; the manufacturer given most often on reports is Lightlab Imaging. Spellings of one product vary from report to report.
80 reports arrived in the 12 months to August 2026, up 60% from 50 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 (70.4%), injury (27.8%) and death (1.8%); across all transducer, pressure, catheter tip reports (product code DXO) death is recorded in 0.9% and malfunction in 81%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material separation (26.6%), break (22.5%) and difficult to remove (18.9%). The patient problems coded most often are device embedded in tissue or plaque, vascular dissection and angina. 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 2,406 reports carrying product code DXO. 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 |
|---|---|---|---|
| Material separation | 45 | 26.6% | 5.2% |
| Breakthe device broke | 38 | 22.5% | 6.7% |
| Difficult to removethe device was hard to remove | 32 | 18.9% | 3.4% |
| Communication or transmission problemthe device could not communicate or transmit | 30 | 17.8% | 5.3% |
| Deformation due to compressive stress | 18 | 10.7% | 1.7% |
| Difficult to advance | 18 | 10.7% | 1.5% |
| Incorrect, inadequate or imprecise result or readings | 18 | 10.7% | 15.8% |
| Improper or incorrect procedure or method | 13 | 7.7% | 1.5% |
| Peeled/delaminated | 10 | 5.9% | 1% |
| Difficult or delayed positioning | 9 | 5.3% | 0.4% |
| Failure to advance | 9 | 5.3% | 2.6% |
| Material split, cut or torn | 8 | 4.7% | 0.8% |
| Stretched | 4 | 2.4% | 0.5% |
| Material twisted/bent | 3 | 1.8% | 0.3% |
| Device difficult to setup or prepare | 2 | 1.2% | 0.2% |
| Insufficient device problem information | 2 | 1.2% | 0.5% |
| Material frayed | 2 | 1.2% | 0.2% |
| Product quality problem | 2 | 1.2% | 0.1% |
| Contamination /decontamination problem | 1 | 0.6% | 0.8% |
| Corrodedthe device corroded | 1 | 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 |
|---|---|---|
| Device embedded in tissue or plaque | 11 | 6.5% |
| Vascular dissection | 9 | 5.3% |
| Angina | 3 | 1.8% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.8% |
| Myocardial infarctionheart attack | 2 | 1.2% |
| Obstruction/occlusion | 2 | 1.2% |
| Perforation of vessels | 2 | 1.2% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 2 | 1.2% |
| Air embolism | 1 | 0.6% |
| Arrhythmia | 1 | 0.6% |
| Ischemia | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
| Non specific ekg/ECG changes | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PressureWire | Product code DXO | All MAUDE reports |
|---|---|---|---|
| Reports | 169 | 2,406 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 18 | 9 | 9 |
| Classified as injury | 27.8% | 17.5% | 36.2% |
| Classified as malfunction | 70.4% | 81% | 62.3% |
| Filed by the manufacturer | 91.7% | 93.8% | 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 DXO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pressure Monitoring Kit | 281 | 0 | 0.7% |
| TruWave Disposable Pressure Transducer | 624 | 67 | 0.5% |
| Comet | 231 | 0 | 1.3% |
| Pressurewire X Wireless Rx 175cm | 150 | 0 | 1.3% |
| FloTrac Sensor | 194 | 10 | 0% |
| Acist | 348 | 14 | 10.6% |
| Tego Connector | 1,179 | 212 | 0.3% |
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 PressureWire reports
How many FDA reports name PressureWire?
169 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 80 in the latest 12 months.
What kinds of events are reported?
malfunction (70.4%), injury (27.8%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (26.6%), break (22.5%), difficult to remove (18.9%), communication or transmission problem (17.8%) and deformation due to compressive stress (10.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (91.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PressureWire 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.