Catheter, septostomy: medical device reports filed with FDA

2,205 reports carry this product code, 1994–2026; 5 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,205
reports with this product code: 0% of all MAUDE reports; 793
reports, 12 months to August 2026: 604 in the 12 months before; 30.7%
classified as malfunction: 62.3% across all reports; 4.9%
classified as death, as reported: 0.9% across all reports

Product code DXF is FDA's classification for "Catheter, septostomy" (cardiovascular panel), a class 2 device. 2,205 medical device reports carry this product code, 0% of the MAUDE database, from August 1994 to August 2026.

793 reports arrived in the 12 months to August 2026, up 31% from 604 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 injury (64.2%), malfunction (30.7%) and death (4.9%). 5 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
VersaCross Connect LAAC Access Solution	672	371	6%	22.7%
VersaCross Connect Access Solution for FARADRIVE	352	280	1.9%	45.7%
NRG Transseptal Needle	262	24	4.2%	25.9%
VersaCross Access Solution	257	144	7.9%	29.7%
RF Needle	175	64	0.6%	82.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Baylis Medicale Cie	970	44%
Baylis Medical	706	32%
Edwards Lifesciences Pr	18	0.8%
B Braun Medical	3	0.1%
Bard	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death4.9%107

Injury64.2%1,415

Malfunction30.7%677

Other0.2%4

Not given0.1%2

Who filed

Manufacturer report96.1%2,118

Voluntary report2.9%63

User facility report0%0

Distributor report0%0

Not given1.1%24

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Difficult to advance	251	11.4%
Failure to advance	225	10.2%
Material integrity problema problem with the device material	185	8.4%
Display or visual feedback problem	107	4.9%
Positioning problem	97	4.4%
Material deformation	79	3.6%
Physical resistance/sticking	72	3.3%
Device sensing problem	55	2.5%
Detachment of device or device componentpart of the device came off	43	2%
Off-label use	42	1.9%
Nonstandard device	32	1.5%
Device-device incompatibility	31	1.4%
Difficult to removethe device was hard to remove	30	1.4%
Deformation due to compressive stress	24	1.1%
Burst container or vessel	23	1%
Device dislodged or dislocated	22	1%
Defective devicethe device was defective	21	1%
Difficult to insertthe device was hard to insert	21	1%
Insufficient device problem information	18	0.8%
Material frayed	17	0.8%

Questions about catheter, septostomy reports

What is product code DXF?

FDA's classification code for "Catheter, septostomy", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,205 reports through August 2026, 793 of them in the latest 12 months.

Which brands appear most often?

VersaCross Connect LAAC Access Solution (672), VersaCross Connect Access Solution for FARADRIVE (352), NRG Transseptal Needle (262), VersaCross Access Solution (257) and RF Needle (175). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.