Devices › Catheter, septostomy
Device brand name · Catheter septostomy
RF Needle: medical device reports filed with FDA
180 reports name it, 2023–2026. Manufacturer given most often on reports: Baylis Medical. Product code DXF.
- 180
- device reports naming the brand
- 0% of all MAUDE reports · about 58 a year
- 64
- reports, 12 months to August 2026
- 54 in the 12 months before
- 82.8%
- classified as malfunction
- 30.7% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 180 reports that name the brand "RF Needle" (catheter septostomy), received between June 2023 and July 2026; the manufacturer given most often on reports is Baylis Medical. Spellings of one product vary from report to report.
64 reports arrived in the 12 months to August 2026, up 19% from 54 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 (82.8%), injury (16.1%) and death (0.6%); across all catheter, septostomy reports (product code DXF) death is recorded in 4.9% and malfunction in 30.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to advance (41.7%), detachment of device or device component (15.6%) and difficult to advance (7.8%). 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 2,205 reports carrying product code DXF. 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 |
|---|---|---|---|
| Failure to advance | 75 | 41.7% | 10.2% |
| Detachment of device or device componentpart of the device came off | 28 | 15.6% | 2% |
| Difficult to advance | 14 | 7.8% | 11.4% |
| Material integrity problema problem with the device material | 14 | 7.8% | 8.4% |
| Material deformation | 12 | 6.7% | 3.6% |
| Off-label use | 9 | 5% | 1.9% |
| Physical resistance/sticking | 9 | 5% | 3.3% |
| Nonstandard device | 8 | 4.4% | 1.5% |
| Packaging problem | 6 | 3.3% | 0.6% |
| Contamination | 5 | 2.8% | 0.7% |
| Defective devicethe device was defective | 4 | 2.2% | 1% |
| Device-device incompatibility | 3 | 1.7% | 1.4% |
| Failure to deliver energy | 3 | 1.7% | 0.5% |
| Deformation due to compressive stress | 2 | 1.1% | 1.1% |
| Device contamination with chemical or other material | 2 | 1.1% | 0% |
| Difficult to open or remove packaging material | 2 | 1.1% | 0.3% |
| Obstruction of flow | 2 | 1.1% | 0.1% |
| Device displays incorrect message | 1 | 0.6% | 0.4% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.6% | 0% |
| Device sensing problem | 1 | 0.6% | 2.5% |
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 | 20 | 11.1% |
| Cardiac tamponade | 19 | 10.6% |
| Low blood pressure/ hypotension | 16 | 8.9% |
| Cardiac perforation | 8 | 4.4% |
| Perforation | 2 | 1.1% |
| Tachycardiafast heart rate | 2 | 1.1% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Hemothorax | 1 | 0.6% |
| Needle stick/puncture | 1 | 0.6% |
| Thrombosis/thrombus | 1 | 0.6% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | RF Needle | Product code DXF | All MAUDE reports |
|---|---|---|---|
| Reports | 180 | 2,205 | 26,136,888 |
| Share of that pool | — | 8.2% | 0% |
| Classified as death, per 1,000 reports | 6 | 49 | 9 |
| Classified as injury | 16.1% | 64.2% | 36.2% |
| Classified as malfunction | 82.8% | 30.7% | 62.3% |
| Filed by the manufacturer | 97.2% | 96.1% | 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 DXF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| VersaCross Connect LAAC Access Solution | 1,111 | 371 | 6% |
| VersaCross Connect Access Solution for FARADRIVE | 569 | 280 | 1.9% |
| NRG Transseptal Needle | 263 | 24 | 4.2% |
| VersaCross Access Solution | 418 | 144 | 7.9% |
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 RF Needle reports
How many FDA reports name RF Needle?
180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 64 in the latest 12 months.
What kinds of events are reported?
malfunction (82.8%), injury (16.1%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (41.7%), detachment of device or device component (15.6%), difficult to advance (7.8%), material integrity problem (7.8%) and material deformation (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.2%) and voluntary reports (2.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that RF Needle 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.