Dialyzer, capillary, hollow fiber: medical device reports filed with FDA

8,433 reports carry this product code, 1992–2026; 23 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.

8,433
reports with this product code: 0% of all MAUDE reports; 138
reports, 12 months to August 2026: 141 in the 12 months before; 55.2%
classified as malfunction: 62.3% across all reports; 1.9%
classified as death, as reported: 0.9% across all reports

Product code FJI is FDA's classification for "Dialyzer, capillary, hollow fiber" (gastroenterology, Urology panel), a class 2 device. 8,433 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

138 reports arrived in the 12 months to August 2026, close to the 141 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 malfunction (55.2%), injury (37.6%) and other (4.4%). 23 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
Optiflux 180nre Dialyzer Finished Assy	1,226	69	0.6%	85.3%
Ct Gamma Dialyzer Ct 190g	1,011	0	0.3%	94.9%
Optiflux 160nre Dialyzer Finished Assy	936	27	0.8%	87.5%
Polyflux	389	116	0.3%	79.9%
Unknown Distributed Dialyzer	361	0	0%	0.8%
Terumo Taf175 Hf/Cr/1 75/M	240	0	0%	0.8%
Psn Dialyzer Psn 210	231	0	0.8%	76.4%
Clirans Taf Hf Dialyzer	212	0	0%	39.6%
Ca-Hp Dialyzer Ca-Hp 210	176	0	1.1%	85.9%
Optiflux 200nre Dialyzer Finished Assy	175	5	0.5%	92%
Terumo	90	0	2.8%	12.2%
Fresenius	86	0	6.1%	13.7%
Dialyzer	55	69	2.2%	57.4%
Baxter	21	3	3.8%	54.2%
Optiflux F250nre Dialyzer	15	0	0.4%	93.8%
Fusa F80a Hf/Ps/1 8/H	9	0	1.2%	16.9%
Fusa F80b Hf/Ps/1 8/H	8	0	0%	13.7%
Revaclear	2	19	1.1%	72.8%
1550 Hemodialysis Machine	1	0	10.6%	53.3%
Combi Set	1	0	3.4%	93.2%
Naturalyte	1	0	82.2%	0%
Polyflux L Capillary Dialyzer	1	0	1.3%	60.6%
Ultrafilter Hechingen	1	25	0%	95.5%

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
Fresenius Medical Care North America	1,669	19.8%
Nissho	1,186	14.1%
Baxter Healthcare	943	11.2%
Terumo	759	9%
Ogden Manufacturing Plant	291	3.5%
Vantive US Healthcare	194	2.3%
Terumo Ashitaka	142	1.7%
Fresenius USA	106	1.3%
Gambro Healthcare	52	0.6%
Terumo Medical	25	0.3%
Gambro Dialysatoren	15	0.2%
Medcomp	1	0%
Reynosa Manufacturing	1	0%

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

Death1.9%157

Injury37.6%3,169

Malfunction55.2%4,659

Other4.4%370

Not given0.9%78

Who filed

Manufacturer report75.4%6,356

Voluntary report1.5%128

User facility report0%0

Distributor report21.4%1,801

Not given1.8%148

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	3,000	35.6%
Leak/splashthe device leaked	1,786	21.2%
Replace	1,332	15.8%
Reactiona reaction, type not specified	463	5.5%
Reuse	356	4.2%
Device contamination with body fluid	255	3%
Alarm, audible	201	2.4%
Crackthe device cracked	166	2%
Repair	128	1.5%
Membrane leak(s)	105	1.2%
Insufficient device problem information	92	1.1%
Breakthe device broke	73	0.9%
Other (for use when an appropriate device code cannot be identified)	65	0.8%
Malfunction	56	0.7%
Blood in tubing	51	0.6%
Coagulation in device or device ingredient	49	0.6%
Compatibility	45	0.5%
Device displays incorrect message	41	0.5%
Tears, rips, holes in device, device material	39	0.5%
Occlusion within devicethe device blocked	37	0.4%

Questions about dialyzer, capillary, hollow fiber reports

What is product code FJI?

FDA's classification code for "Dialyzer, capillary, hollow fiber", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,433 reports through August 2026, 138 of them in the latest 12 months.

Which brands appear most often?

Optiflux 180nre Dialyzer Finished Assy (1,226), Ct Gamma Dialyzer Ct 190g (1,011), Optiflux 160nre Dialyzer Finished Assy (936), Polyflux (389) and Unknown Distributed Dialyzer (361). 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.