Devices › System, hemodynamic, implantable
Device brand name · System hemodynamic implantable
HF Sensor Delivery System: medical device reports filed with FDA
5,311 reports name it, 2015–2026. Manufacturer given most often on reports: St Jude Medical. Product code MOM.
- 5,311
- device reports naming the brand
- 0% of all MAUDE reports · about 487 a year
- 757
- reports, 12 months to August 2026
- 736 in the 12 months before
- 19.3%
- classified as malfunction
- 62.4% across the product code
- 4%
- classified as death, as reported
- 215 reports · not verified by FDA
FDA's MAUDE database holds 5,311 reports that name the brand "HF Sensor Delivery System" (system hemodynamic implantable), received between August 2015 and August 2026; the manufacturer given most often on reports is St Jude Medical. Spellings of one product vary from report to report.
757 reports arrived in the 12 months to August 2026, close to the 736 of 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 (76.6%), malfunction (19.3%) and death (4%); across all system, hemodynamic, implantable reports (product code MOM) death is recorded in 1.9% and malfunction in 62.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect measurement (52.9%), device sensing problem (18.6%) and inappropriate waveform (10.3%). The patient problems coded most often are hemoptysis, death and dyspnea. 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 11,974 reports carrying product code MOM. 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 |
|---|---|---|---|
| Incorrect measurementthe device measured wrongly | 2,811 | 52.9% | 24.2% |
| Device sensing problem | 990 | 18.6% | 8.3% |
| Inappropriate waveform | 549 | 10.3% | 4.6% |
| Insufficient device problem information | 108 | 2% | 0.9% |
| Migrationthe device moved from where it was placed | 86 | 1.6% | 0.7% |
| Difficult to advance | 57 | 1.1% | 0.5% |
| Difficult or delayed separation | 42 | 0.8% | 0.3% |
| Failure to read input signal | 42 | 0.8% | 0.9% |
| Unable to obtain readings | 39 | 0.7% | 0.3% |
| Incorrect, inadequate or imprecise result or readings | 28 | 0.5% | 0.4% |
| Failure to advance | 24 | 0.5% | 0.2% |
| Calibration problem | 22 | 0.4% | 0.2% |
| Difficult to removethe device was hard to remove | 21 | 0.4% | 0.2% |
| Positioning problem | 15 | 0.3% | 0.1% |
| Device damaged by another device | 9 | 0.2% | 0.1% |
| Entrapment of device | 9 | 0.2% | 0.1% |
| Failure to calibrate | 9 | 0.2% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 8 | 0.2% | 0.2% |
| Improper or incorrect procedure or method | 7 | 0.1% | 0.1% |
| Application program problem | 6 | 0.1% | 5.6% |
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 |
|---|---|---|
| Hemoptysis | 199 | 3.7% |
| Deaththe patient died; cause not stated by this term | 172 | 3.2% |
| Dyspneashortness of breath | 63 | 1.2% |
| Hypervolemia | 48 | 0.9% |
| Heart failure/congestive heart failure | 35 | 0.7% |
| Low blood pressure/ hypotension | 31 | 0.6% |
| Pulmonary embolisma blood clot in the lung | 30 | 0.6% |
| Heart failure | 27 | 0.5% |
| Great vessel perforation | 23 | 0.4% |
| Hematomaa collection of blood under the skin or in tissue | 20 | 0.4% |
| Thrombosis/thrombus | 20 | 0.4% |
| Chest painchest pain | 17 | 0.3% |
| Coughcough | 16 | 0.3% |
| Hemorrhage/blood loss/bleeding | 13 | 0.2% |
| Swelling/ edema | 13 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | HF Sensor Delivery System | Product code MOM | All MAUDE reports |
|---|---|---|---|
| Reports | 5,311 | 11,974 | 26,136,888 |
| Share of that pool | — | 44.4% | 0% |
| Classified as death, per 1,000 reports | 40 | 19 | 9 |
| Classified as injury | 76.6% | 35.6% | 36.2% |
| Classified as malfunction | 19.3% | 62.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.7% | 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 MOM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cardiomems Patient Electronic System | 4,593 | 738 | 0% |
| CARDIOMEMS Power Supply | 802 | 350 | 0% |
| CardioMEMS Hospital System | 470 | 135 | 0% |
| Merlin Net / Hf Portal | 259 | 34 | 0% |
| Power cord 110V | 244 | 93 | 0% |
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 HF Sensor Delivery System reports
How many FDA reports name HF Sensor Delivery System?
5,311 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 757 in the latest 12 months.
What kinds of events are reported?
injury (76.6%), malfunction (19.3%) and death (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect measurement (52.9%), device sensing problem (18.6%), inappropriate waveform (10.3%), insufficient device problem information (2%) and migration (1.6%). 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 HF Sensor Delivery System 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.