Devices › Catheter, intravascular, therapeutic, long-term greater than 30 days
Device brand name · Convenience kit
Navilyst Medical: medical device reports filed with FDA
252 reports name it, 2008–2015. Manufacturer given most often on reports: Navilyst Medical. Product code LJS.
- 252
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 90.9%
- classified as malfunction
- 81.1% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 252 reports that name the brand "Navilyst Medical" (convenience kit), received between September 2008 and September 2015; the manufacturer given most often on reports is Navilyst Medical. 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 malfunction (90.9%), injury (8.3%) and death (0.4%); 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 air leak (45.6%), hole in material (18.7%) and device contamination with chemical or other material (8.3%). The patient problems coded most often are no patient involvement, air embolism and chest 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
No report naming Navilyst Medical was received in the five years to August 2026; the latest was received in September 2015.
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 |
|---|---|---|---|
| Air leak | 115 | 45.6% | 0.2% |
| Hole in material | 47 | 18.7% | 1.9% |
| Device contamination with chemical or other material | 21 | 8.3% | 0.3% |
| Device disinfection or sterilization issue | 11 | 4.4% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 4% | 0.8% |
| Breakthe device broke | 9 | 3.6% | 11.5% |
| Detachment of device component | 7 | 2.8% | 2% |
| Leak/splashthe device leaked | 7 | 2.8% | 6.2% |
| Delivered as unsterile product | 5 | 2% | 0% |
| Device contaminated during manufacture or shipping | 5 | 2% | 0% |
| Difficult to removethe device was hard to remove | 5 | 2% | 1.8% |
| Aspiration issue | 4 | 1.6% | 0.2% |
| Bubble(s) | 4 | 1.6% | 0% |
| Crackthe device cracked | 4 | 1.6% | 3.4% |
| Defective devicethe device was defective | 4 | 1.6% | 0.3% |
| Device packaging compromised | 4 | 1.6% | 0% |
| Improper or incorrect procedure or method | 4 | 1.6% | 0.6% |
| Bent | 3 | 1.2% | 0.2% |
| Connection problema connection problem | 3 | 1.2% | 0.1% |
| Fluid/blood leak | 3 | 1.2% | 30.1% |
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 |
|---|---|---|
| No patient involvement | 18 | 7.1% |
| Air embolism | 12 | 4.8% |
| Chest painchest pain | 3 | 1.2% |
| Hemorrhage/blood loss/bleeding | 3 | 1.2% |
| Painpain, site not specified | 3 | 1.2% |
| Therapy/non-surgical treatment, additional | 3 | 1.2% |
| Stroke/cva | 2 | 0.8% |
| Treatment with medication(s) | 2 | 0.8% |
| Arrhythmia | 1 | 0.4% |
| Burning sensationa burning feeling | 1 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.4% |
| Chemical exposure | 1 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
| Device embedded in tissue or plaque | 1 | 0.4% |
| Embolism | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Navilyst Medical | Product code LJS | All MAUDE reports |
|---|---|---|---|
| Reports | 252 | 37,016 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 8.3% | 16.8% | 36.2% |
| Classified as malfunction | 90.9% | 81.1% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| Premicath | 338 | 54 | 3.6% |
| 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% |
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 Navilyst Medical reports
How many FDA reports name Navilyst Medical?
252 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?
malfunction (90.9%), injury (8.3%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
air leak (45.6%), hole in material (18.7%), device contamination with chemical or other material (8.3%), device disinfection or sterilization issue (4.4%) and device operates differently than expected (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and distributor reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Navilyst Medical 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.