Reported Reactions

Devices › Port & catheter, implanted, subcutaneous, intravascular

Device brand name · Vascular access device

Lifeport Vascular Access System: medical device reports filed with FDA

609 reports name it, 1992–2004. Manufacturer given most often on reports: Horizon Medical Products. Product code LJT.

609
device reports naming the brand
0% of all MAUDE reports · about 18 a year
0
reports, 12 months to August 2026
0 in the 12 months before
17.7%
classified as malfunction
38.6% across the product code
0.5%
classified as death, as reported
3 reports · not verified by FDA

FDA's MAUDE database holds 609 reports that name the brand "Lifeport Vascular Access System" (vascular access device), received between April 1992 and July 2004; the manufacturer given most often on reports is Horizon Medical Products. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (77.8%), malfunction (17.7%) and other (3.8%); across all port & catheter, implanted, subcutaneous, intravascular reports (product code LJT) death is recorded in 1.8% and malfunction in 38.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are explanted (47.6%), component(s), broken (29.2%) and fracture (26.6%). The patient problems coded most often are surgical procedure, therapy/non-surgical treatment, additional and surgical procedure, repeated. 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

No report naming Lifeport Vascular Access System was received in the five years to August 2026; the latest was received in July 2004.

By year received

0831651992: 419921993: 51994: 319941996: 341997: 16519971998: 841999: 5319992000: 852001: 7220012002: 702003: 1920032004: 15

Event type and report source

Event type, as classified on the report

Death0.5%3
Injury77.8%474
Malfunction17.7%108
Other3.8%23
Not given0.2%1

Who filed the report

Manufacturer report97%591
Voluntary report0.5%3
User facility report0%0
Distributor report0.2%1
Not given2.3%14

Grey bar: all 22,475 reports carrying product code LJT. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Explanted29047.6%8.6%
Component(s), broken17829.2%2.3%
Fracturea broken bone16226.6%23.6%
Leak/splashthe device leaked14323.5%3.3%
Replace9715.9%3.2%
Migration or expulsion of device8313.6%5.4%
Breakthe device broke528.5%8.5%
Occlusion within devicethe device blocked498%1%
Tears, rips, holes in device, device material345.6%1.1%
Crackthe device cracked315.1%1.1%
Material separation274.4%9%
Difficult to insertthe device was hard to insert243.9%1.4%
Device issuea problem with the device203.3%0.7%
Other (for use when an appropriate device code cannot be identified)203.3%0.5%
Fluid/blood leak172.8%9.1%
Implant, removal of172.8%2.1%
Malfunction152.5%0.5%
Detachment of device component132.1%1.9%
Difficult to removethe device was hard to remove132.1%2.9%
Flushing problem132.1%0.7%

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)ReportsShare
Surgical procedure17128.1%
Therapy/non-surgical treatment, additional7412.2%
Surgical procedure, repeated7312%
Foreign body, removal of498%
Painpain, site not specified498%
Surgical procedure, additional426.9%
Swellingswelling416.7%
Failure of implant304.9%
Extravasation223.6%
Embolism152.5%
Migrationthe device moved from where it was placed142.3%
Other (for use when an appropriate patient code cannot be identified)142.3%
Hospitalization required101.6%
Burning sensationa burning feeling71.1%
Nonresorbable materials, unretrieved in body71.1%

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

In context

MeasureLifeport Vascular Access SystemProduct code LJTAll MAUDE reports
Reports60922,47526,136,888
Share of that pool—2.7%0%
Classified as death, per 1,000 reports5189
Classified as injury77.8%57.7%36.2%
Classified as malfunction17.7%38.6%62.3%
Filed by the manufacturer97%83.8%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 LJT

BrandReportsLatest 12 monthsClassified as death
PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F1,3276564.7%
PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F1,0432111.3%
PowerPort M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F6893414.2%
PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F6693504.6%
PowerPort isp MRI 6F CHRONW/OS4561830%
Celsite452510.9%
Unknown Port435160.7%
Implanted Port4003684.3%
Smart Port CT3321924.2%
PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F2951645.4%
Unknown Power Port29351.7%
PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F279743.2%
PowerPort isp MRI 6CF Int w SP, ATT, SL2771400%
Power Port isp M.R.I., 8Fr Groshong225360%
M.R.I. Implantable Port, Hickman Single-Lumen, 9.6F213622.3%

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 Lifeport Vascular Access System reports

How many FDA reports name Lifeport Vascular Access System?

609 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (77.8%), malfunction (17.7%) and other (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

explanted (47.6%), component(s), broken (29.2%), fracture (26.6%), leak/splash (23.5%) and replace (15.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (97%), voluntary reports (0.5%) and distributor reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Lifeport Vascular Access 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.