Shunt, central nervous system and components: medical device reports filed with FDA

25,520 reports carry this product code, 1992–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

25,520
reports with this product code: 0.1% of all MAUDE reports; 1,202
reports, 12 months to August 2026: 1,272 in the 12 months before; 31.2%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

Product code JXG is FDA's classification for "Shunt, central nervous system and components" (neurology panel), a class 2 device. 25,520 medical device reports carry this product code, 0.1% of the MAUDE database, from April 1992 to August 2026.

1,202 reports arrived in the 12 months to August 2026, close to the 1,272 of 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 (64%), malfunction (31.2%) and other (1.6%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Hakim Programmable Valve With Prechamber	948	0	0.3%	3.3%
Strata	815	163	2.2%	53.6%
Hakim Programmable Valve	690	9	0.9%	9.1%
Unknown Strata Valve/Shunt	515	0	2.3%	40.6%
Hakim Inline Programmable Valve Sg	343	0	0%	7.3%
Certas Inlin Vlv Sphn/Unit Cat	337	0	0.6%	8%
Hakim Valve	337	0	0%	8%
Certas Inlin Vlv Only W/Sphngd	327	0	0.9%	12.2%
NT821731C, EDS 3, GEN ll, NO CATHETER	326	127	0%	97.9%
Unknown Valve/Shunt	225	10	5.8%	19.6%
Prog Valve Inline W Sg	222	10	0%	12.2%
Hakim Prog Valve Inline Siphonguard	210	0	0.5%	10.5%
Programmable Valve In-Line W/Siphonguard	186	0	0%	15.6%
Progav 2 0 Valve	183	21	0%	4.9%
Unknown Catheter	182	26	2.2%	38.1%
Strata 2 Adjustable Valve Regular	174	0	0.6%	71.8%
Hakim Programmable Valve Without Prechamber	152	0	0%	3.3%
Hermetic Lumbar Catheter, Closed Tip	150	15	0%	62.7%
Delta	66	22	7.2%	63.9%
Codman	37	0	1.6%	57.9%
EDM Lumbar Drainage Kit	9	54	0.5%	80.7%
Medtronic	5	17	4.4%	23.5%
Microsensor Ventricular Catheter Kit	5	2	1.3%	39.8%
Becker	4	18	0%	92.3%
Cordis	4	0	9.3%	20.6%
Codman Dispos Perforator	2	21	0%	53.7%
Neuromonitor Basic Kit	2	18	0.4%	26.9%
Catheter	1	9	3.7%	27.9%
Codman Disposable Perforator	1	0	0.2%	44.2%
Codman Malis Integrated Tube Set Unitized Plug	1	0	0%	94.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Neurosurgery	6,624	26%
Christoph Miethke & Kg	3,464	13.6%
Codman & Shurtleff	1,897	7.4%
Integra Lifesciences Switzerland Sar	1,861	7.3%
Codman & Shurtleff / Medos	1,719	6.7%
Codman & Shurtleff Medos	963	3.8%
Integra Neurosciences Pr	745	2.9%
Integra Lifesciences Mansfield	731	2.9%
Medtronic Dominicana	648	2.5%
Natus Medical	461	1.8%
Covidien	422	1.7%
Raynham	268	1.1%
Integra Lifesciences	126	0.5%
Medos International Sarl	64	0.3%
Codman And Shurtleff	28	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.9%222

Injury64%16,321

Malfunction31.2%7,952

Other1.6%412

Not given2.4%613

Who filed

Manufacturer report95.1%24,265

Voluntary report1.7%438

User facility report0%0

Distributor report0.4%108

Not given2.8%709

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Infusion or flow problema problem with flow or infusion	2,811	11%
Explanted	2,695	10.6%
Breakthe device broke	2,150	8.4%
Other (for use when an appropriate device code cannot be identified)	1,522	6%
Leak/splashthe device leaked	1,486	5.8%
Obstruction of flow	1,486	5.8%
Insufficient device problem information	1,330	5.2%
Mechanical problema mechanical problem	1,308	5.1%
Replace	1,081	4.2%
Occlusion within devicethe device blocked	996	3.9%
Fluid/blood leak	772	3%
Device operates differently than expectedthe device behaved unexpectedly	686	2.7%
Fracturea broken bone	658	2.6%
Program, failure to	613	2.4%
Partial blockage	608	2.4%
Valve(s), failure of	539	2.1%
Disconnection	520	2%
Programming issue	492	1.9%
Device issuea problem with the device	444	1.7%
No flow	430	1.7%

Questions about shunt, central nervous system and components reports

What is product code JXG?

FDA's classification code for "Shunt, central nervous system and components", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

25,520 reports through August 2026, 1,202 of them in the latest 12 months.

Which brands appear most often?

Hakim Programmable Valve With Prechamber (948), Strata (815), Hakim Programmable Valve (690), Unknown Strata Valve/Shunt (515) and Hakim Inline Programmable Valve Sg (343). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.