Devices › Shunt, central nervous system and components
Device brand name · Shunt central nervous system and components
Unknown Catheter: medical device reports filed with FDA
270 reports name it, 2010–2026. Manufacturer given most often on reports: Medtronic Neurosurgery. Product code JXG.
- 270
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 26
- reports, 12 months to August 2026
- 15 in the 12 months before
- 38.1%
- classified as malfunction
- 31.2% across the product code
- 2.2%
- classified as death, as reported
- 6 reports · not verified by FDA
270 medical device reports received by FDA name the brand "Unknown Catheter" (shunt central nervous system and components); the manufacturer given most often on reports is Medtronic Neurosurgery; received from May 2010 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
26 reports arrived in the 12 months to August 2026, up 73% from 15 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 (59.6%), malfunction (38.1%) and death (2.2%); across all shunt, central nervous system and components reports (product code JXG) death is recorded in 0.9% and malfunction in 31.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (11.1%), complete blockage (8.9%) and insufficient device problem information (8.1%). The patient problems coded most often are therapeutic response, decreased, headache 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 25,520 reports carrying product code JXG. 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 |
|---|---|---|---|
| Breakthe device broke | 30 | 11.1% | 8.4% |
| Complete blockage | 24 | 8.9% | 1.5% |
| Insufficient device problem information | 22 | 8.1% | 5.2% |
| Fracturea broken bone | 20 | 7.4% | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 16 | 5.9% | 2.7% |
| Migrationthe device moved from where it was placed | 16 | 5.9% | 0.4% |
| Disconnection | 9 | 3.3% | 2% |
| Infusion or flow problema problem with flow or infusion | 8 | 3% | 11% |
| Occlusion within devicethe device blocked | 8 | 3% | 3.9% |
| Leak/splashthe device leaked | 7 | 2.6% | 5.8% |
| Migration or expulsion of device | 6 | 2.2% | 0.5% |
| Device contamination with chemical or other material | 4 | 1.5% | 0.1% |
| Activation problem | 3 | 1.1% | 0% |
| Fluid/blood leak | 3 | 1.1% | 3% |
| Material integrity problema problem with the device material | 3 | 1.1% | 0.3% |
| Insufficient flow or under infusion | 2 | 0.7% | 0.7% |
| Kinkedthe tube or line kinked | 2 | 0.7% | 0.2% |
| Mechanical jam | 2 | 0.7% | 0.7% |
| Retraction problem | 2 | 0.7% | 0% |
| Aspiration issue | 1 | 0.4% | 0% |
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 |
|---|---|---|
| Therapeutic response, decreased | 39 | 14.4% |
| Headachehead pain | 14 | 5.2% |
| Painpain, site not specified | 10 | 3.7% |
| Device embedded in tissue or plaque | 9 | 3.3% |
| Hemorrhage/blood loss/bleeding | 7 | 2.6% |
| Cerebrospinal fluid leakage | 6 | 2.2% |
| Intracranial hemorrhage | 6 | 2.2% |
| Cognitive changes | 5 | 1.9% |
| Fever | 5 | 1.9% |
| Vomitingbeing sick | 5 | 1.9% |
| Cyst(s) | 4 | 1.5% |
| Itching sensation | 4 | 1.5% |
| Muscle weakness/atrophy | 4 | 1.5% |
| Nauseafeeling sick | 4 | 1.5% |
| No patient involvement | 4 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Catheter | Product code JXG | All MAUDE reports |
|---|---|---|---|
| Reports | 270 | 25,520 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 22 | 9 | 9 |
| Classified as injury | 59.6% | 64% | 36.2% |
| Classified as malfunction | 38.1% | 31.2% | 62.3% |
| Filed by the manufacturer | 99.6% | 95.1% | 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 JXG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hakim Programmable Valve With Prechamber | 948 | 0 | 0.3% |
| Strata | 817 | 163 | 2.2% |
| Hakim Programmable Valve | 693 | 9 | 0.9% |
| Unknown Strata Valve/Shunt | 515 | 0 | 2.3% |
| Hakim Inline Programmable Valve Sg | 343 | 0 | 0% |
| Certas Inlin Vlv Sphn/Unit Cat | 337 | 0 | 0.6% |
| Hakim Valve | 337 | 0 | 0% |
| Certas Inlin Vlv Only W/Sphngd | 327 | 0 | 0.9% |
| NT821731C, EDS 3, GEN ll, NO CATHETER | 326 | 127 | 0% |
| Unknown Valve/Shunt | 225 | 10 | 5.8% |
| Prog Valve Inline W Sg | 222 | 10 | 0% |
| Hakim Prog Valve Inline Siphonguard | 210 | 0 | 0.5% |
| Programmable Valve In-Line W/Siphonguard | 186 | 0 | 0% |
| Progav 2 0 Valve | 183 | 21 | 0% |
| Strata 2 Adjustable Valve Regular | 174 | 0 | 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 Unknown Catheter reports
How many FDA reports name Unknown Catheter?
270 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.
What kinds of events are reported?
injury (59.6%), malfunction (38.1%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (11.1%), complete blockage (8.9%), insufficient device problem information (8.1%), fracture (7.4%) and device operates differently than expected (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Catheter 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.