Devices › Port & catheter, implanted, subcutaneous, intravascular
Device brand name · Port & catheter
Smart Port: medical device reports filed with FDA
154 reports name it, 2015–2025. Manufacturer given most often on reports: Angiodynamics. Product code LJT.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 7
- reports, 12 months to August 2026
- 4 in the 12 months before
- 66.2%
- classified as malfunction
- 38.6% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
154 medical device reports received by FDA name the brand "Smart Port" (port & catheter); the manufacturer given most often on reports is Angiodynamics; received from January 2015 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
7 reports arrived in the 12 months to August 2026, up 75% from 4 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 (66.2%), injury (30.5%) and death (0.6%); 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 fracture (40.3%), fluid/blood leak (9.1%) and infusion or flow problem (6.5%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and pain. 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 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) | Reports | Share | Share across product code |
|---|---|---|---|
| Fracturea broken bone | 62 | 40.3% | 23.6% |
| Fluid/blood leak | 14 | 9.1% | 9.1% |
| Infusion or flow problema problem with flow or infusion | 10 | 6.5% | 0.2% |
| Detachment of device or device componentpart of the device came off | 9 | 5.8% | 2% |
| Difficult to removethe device was hard to remove | 6 | 3.9% | 2.9% |
| Material split, cut or torn | 6 | 3.9% | 0.4% |
| Material puncture/hole | 5 | 3.2% | 0.9% |
| Output problem | 4 | 2.6% | 0% |
| Inability to irrigate | 3 | 1.9% | 0% |
| Failure to infuse | 2 | 1.3% | 0.7% |
| Insufficient device problem information | 2 | 1.3% | 1% |
| Migration or expulsion of device | 2 | 1.3% | 5.4% |
| Obstruction of flow | 2 | 1.3% | 3.7% |
| Tear, rip or hole in device packaging | 2 | 1.3% | 0.4% |
| Connection problema connection problem | 1 | 0.6% | 0.2% |
| Crackthe device cracked | 1 | 0.6% | 1.1% |
| Deformation due to compressive stress | 1 | 0.6% | 5.7% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.6% | 0% |
| Insufficient flow or under infusion | 1 | 0.6% | 0% |
| Malposition of device | 1 | 0.6% | 0.3% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 25 | 16.2% |
| Device embedded in tissue or plaque | 20 | 13% |
| Painpain, site not specified | 8 | 5.2% |
| Skin erosion | 6 | 3.9% |
| Infiltration into tissue | 4 | 2.6% |
| Swelling/ edema | 3 | 1.9% |
| Cardiac tamponade | 2 | 1.3% |
| Discomfortdiscomfort | 2 | 1.3% |
| Fluid discharge | 2 | 1.3% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.3% |
| Hypersensitivity/allergic reaction | 2 | 1.3% |
| Post operative wound infection | 2 | 1.3% |
| Swellingswelling | 2 | 1.3% |
| Wound dehiscencea wound reopened | 2 | 1.3% |
| Arrhythmia | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Smart Port | Product code LJT | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 22,475 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 6 | 18 | 9 |
| Classified as injury | 30.5% | 57.7% | 36.2% |
| Classified as malfunction | 66.2% | 38.6% | 62.3% |
| Filed by the manufacturer | 87% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F | 1,327 | 656 | 4.7% |
| PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F | 1,043 | 211 | 1.3% |
| PowerPort M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F | 689 | 341 | 4.2% |
| PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F | 669 | 350 | 4.6% |
| Lifeport Vascular Access System | 609 | 0 | 0.5% |
| PowerPort isp MRI 6F CHRONW/OS | 456 | 183 | 0% |
| Celsite | 452 | 51 | 0.9% |
| Unknown Port | 435 | 16 | 0.7% |
| Implanted Port | 400 | 368 | 4.3% |
| Smart Port CT | 332 | 192 | 4.2% |
| PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F | 295 | 164 | 5.4% |
| Unknown Power Port | 293 | 5 | 1.7% |
| PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F | 279 | 74 | 3.2% |
| PowerPort isp MRI 6CF Int w SP, ATT, SL | 277 | 140 | 0% |
| Power Port isp M.R.I., 8Fr Groshong | 225 | 36 | 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 Smart Port reports
How many FDA reports name Smart Port?
154 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
malfunction (66.2%), injury (30.5%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (40.3%), fluid/blood leak (9.1%), infusion or flow problem (6.5%), detachment of device or device component (5.8%) and difficult to remove (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (87%) and voluntary reports (11%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Smart Port 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.