Device brand name · Catheter septostomy

VersaCross Connect LAAC Access Solution: medical device reports filed with FDA

1,111 reports name it, 2023–2026. Manufacturer given most often on reports: Baylis Medicale Cie. Product code DXF.

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.

1,111
device reports naming the brand: 0% of all MAUDE reports · about 318 a year; 371
reports, 12 months to August 2026: 325 in the 12 months before; 22.7%
classified as malfunction: 30.7% across the product code; 6%
classified as death, as reported: 67 reports · not verified by FDA

1,111 medical device reports received by FDA name the brand "VersaCross Connect LAAC Access Solution" (catheter septostomy); the manufacturer given most often on reports is Baylis Medicale Cie; received from January 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

371 reports arrived in the 12 months to August 2026, up 14% from 325 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 (71.3%), malfunction (22.7%) and death (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 difficult to advance (13.1%), positioning problem (11.9%) and device-device incompatibility (8.7%). The patient problems coded most often are pericardial effusion, low blood pressure/ hypotension and cardiac tamponade. 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

Death6%67

Injury71.3%792

Malfunction22.7%252

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.3%1,103

Voluntary report0.3%3

User facility report0%0

Distributor report0%0

Not given0.5%5

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
Difficult to advance	146	13.1%	11.4%
Positioning problem	132	11.9%	4.4%
Device-device incompatibility	97	8.7%	1.4%
Physical resistance/sticking	97	8.7%	3.3%
Material integrity problema problem with the device material	66	5.9%	8.4%
Display or visual feedback problem	63	5.7%	4.9%
Difficult to removethe device was hard to remove	62	5.6%	1.4%
Material deformation	55	5%	3.6%
Failure to advance	50	4.5%	10.2%
Defective devicethe device was defective	49	4.4%	1%
Device sensing problem	39	3.5%	2.5%
Positioning failure	16	1.4%	0.1%
Nonstandard device	15	1.4%	1.5%
Material perforation	14	1.3%	0%
Deformation due to compressive stress	11	1%	1.1%
Fracturea broken bone	11	1%	0%
Component or accessory incompatibility	9	0.8%	0%
Detachment of device or device componentpart of the device came off	8	0.7%	2%
Off-label use	8	0.7%	1.9%
Thermal decomposition of device	7	0.6%	0.8%

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	588	52.9%
Low blood pressure/ hypotension	292	26.3%
Cardiac tamponade	208	18.7%
Cardiac perforation	200	18%
Thrombosis/thrombus	116	10.4%
Perforation of vessels	78	7%
Hematomaa collection of blood under the skin or in tissue	65	5.9%
Cardiac arrestthe heart stopped	43	3.9%
Hemorrhage/blood loss/bleeding	39	3.5%
Air embolism	31	2.8%
Arrhythmia	28	2.5%
Non specific ekg/ECG changes	27	2.4%
Perforation	26	2.3%
Tachycardiafast heart rate	23	2.1%
Asystole	21	1.9%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	VersaCross Connect LAAC Access Solution	Product code DXF	All MAUDE reports
Reports	1,111	2,205	26,136,888
Share of that pool	—	50.4%	0%
Classified as death, per 1,000 reports	60	49	9
Classified as injury	71.3%	64.2%	36.2%
Classified as malfunction	22.7%	30.7%	62.3%
Filed by the manufacturer	99.3%	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 Access Solution for FARADRIVE	569	280	1.9%
NRG Transseptal Needle	263	24	4.2%
VersaCross Access Solution	418	144	7.9%
RF Needle	180	64	0.6%

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 VersaCross Connect LAAC Access Solution reports

How many FDA reports name VersaCross Connect LAAC Access Solution?

1,111 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 371 in the latest 12 months.

What kinds of events are reported?

injury (71.3%), malfunction (22.7%) and death (6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

difficult to advance (13.1%), positioning problem (11.9%), device-device incompatibility (8.7%), physical resistance/sticking (8.7%) and material integrity problem (5.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.3%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that VersaCross Connect LAAC Access Solution 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.