Devices › Catheter, intravascular, therapeutic, long-term greater than 30 days
Device brand name · Intravascular catheter
Premicath: medical device reports filed with FDA
338 reports name it, 1998–2026. Manufacturer given most often on reports: Vygon USA. Product code LJS.
- 338
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 54
- reports, 12 months to August 2026
- 64 in the 12 months before
- 69.8%
- classified as malfunction
- 81.1% across the product code
- 3.6%
- classified as death, as reported
- 12 reports · not verified by FDA
338 medical device reports received by FDA name the brand "Premicath" (intravascular catheter); the manufacturer given most often on reports is Vygon USA; received from June 1998 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
54 reports arrived in the 12 months to August 2026, down 16% from 64 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 (69.8%), injury (25.7%) and death (3.6%); across all catheter, intravascular, therapeutic, long-term greater than 30 days reports (product code LJS) death is recorded in 0.3% and malfunction in 81.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (40.2%), break (29.9%) and material fragmentation (24.9%). The patient problems coded most often are device embedded in tissue or plaque, foreign body in patient and discomfort. 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 37,016 reports carrying product code LJS. 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 |
|---|---|---|---|
| Fluid/blood leak | 136 | 40.2% | 30.1% |
| Breakthe device broke | 101 | 29.9% | 11.5% |
| Material fragmentation | 84 | 24.9% | 0.8% |
| Migrationthe device moved from where it was placed | 21 | 6.2% | 0.3% |
| Material separation | 15 | 4.4% | 2.3% |
| Difficult to removethe device was hard to remove | 14 | 4.1% | 1.8% |
| Malposition of device | 14 | 4.1% | 0.5% |
| Positioning problem | 14 | 4.1% | 0.3% |
| Fracturea broken bone | 11 | 3.3% | 4.7% |
| Crackthe device cracked | 10 | 3% | 3.4% |
| Material rupture | 10 | 3% | 1.1% |
| Obstruction of flow | 10 | 3% | 1% |
| Material split, cut or torn | 8 | 2.4% | 0.7% |
| Leak/splashthe device leaked | 5 | 1.5% | 6.2% |
| Migration or expulsion of device | 4 | 1.2% | 1.3% |
| Unintended movement | 4 | 1.2% | 0.1% |
| Difficult to flush | 3 | 0.9% | 0.5% |
| Activation, positioning or separation problem | 2 | 0.6% | 0.1% |
| Complete blockage | 2 | 0.6% | 0.2% |
| Device dislodged or dislocated | 2 | 0.6% | 1.2% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 53 | 15.7% |
| Foreign body in patientpart of a device left in the patient | 44 | 13% |
| Discomfortdiscomfort | 15 | 4.4% |
| Pleural effusionfluid around the lung | 13 | 3.8% |
| Hemorrhage/blood loss/bleeding | 9 | 2.7% |
| Cardiac tamponade | 7 | 2.1% |
| Painpain, site not specified | 6 | 1.8% |
| Premature labor | 6 | 1.8% |
| Deaththe patient died; cause not stated by this term | 4 | 1.2% |
| Pericardial effusionfluid around the heart | 4 | 1.2% |
| Failure of implant | 3 | 0.9% |
| Extravasation | 2 | 0.6% |
| Inflammationinflammation | 2 | 0.6% |
| Respiratory distress syndrome of newborns | 2 | 0.6% |
| Swellingswelling | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Premicath | Product code LJS | All MAUDE reports |
|---|---|---|---|
| Reports | 338 | 37,016 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 36 | 3 | 9 |
| Classified as injury | 25.7% | 16.8% | 36.2% |
| Classified as malfunction | 69.8% | 81.1% | 62.3% |
| Filed by the manufacturer | 93.8% | 92.9% | 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 LJS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PowerPICC | 856 | 577 | 0.1% |
| Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer | 774 | 0 | 0.1% |
| Bard PICC | 733 | 84 | 0% |
| PowerPICC SOLO2, 3CG | 692 | 137 | 0% |
| PowerPICC SOLO2 | 680 | 488 | 0% |
| Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray With Microintroducer | 439 | 0 | 0.5% |
| Groshong CLEARVUE | 419 | 415 | 0% |
| Groshong NXT ClearVue | 396 | 150 | 0% |
| Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray | 377 | 0 | 0.3% |
| Powerpicc 3cg | 341 | 18 | 0% |
| Nutriline | 328 | 60 | 0.6% |
| Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray | 309 | 0 | 0% |
| Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f | 264 | 0 | 0% |
| Vaxcel Pasv Picc | 286 | 0 | 0.7% |
| Morpheus Picc | 281 | 0 | 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 Premicath reports
How many FDA reports name Premicath?
338 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 54 in the latest 12 months.
What kinds of events are reported?
malfunction (69.8%), injury (25.7%) and death (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (40.2%), break (29.9%), material fragmentation (24.9%), migration (6.2%) and material separation (4.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.8%) and voluntary reports (0.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Premicath 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.