Device manufacturer, as written on reports

Concord Manufacturing: medical device reports filed with FDA

19,793 reports name it as the manufacturer of the device involved, 2013–2026.

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.

19,793
reports naming it as manufacturer: 0.1% of all MAUDE reports; 5
reports, 12 months to August 2026: 323 in the 12 months before; 74.9%
classified as malfunction: 62.3% across all reports; 3.8%
classified as death, as reported: 0.9% across all reports

19,793 medical device reports received by FDA give Concord Manufacturing as the manufacturer of the device involved, 0.1% of the MAUDE database, from December 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5 reports arrived in the 12 months to August 2026, down 98% from 323 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 (74.9%), injury (21.3%) and death (3.8%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Liberty Select Cycler Assy Non-Valuated	System, peritoneal, automatic delivery	13,448	1,174	3.6%
Liberty Cycler	System, peritoneal, automatic delivery	1,153	0	9%
2008T HEMODIALYSIS SYS., with CDX	Dialyzer, high permeability with or without sealed dialysate system	838	31	4.8%
Ul Liberty Cycler Assembly Non-Valuated	System, peritoneal, automatic delivery	723	1	5.8%
Liberty Select Cycler	System, peritoneal, automatic delivery	553	0	4.8%
Liberty Cycler Ul	System, peritoneal, automatic delivery	540	0	2%
2008k2 Hemodialysis Sys Olc/Diasafe Pls	Dialyzer, high permeability with or without sealed dialysate system	367	3	3.9%
2008t Hd Sys Cdx W/Bibag Blue Star	Dialyzer, high permeability with or without sealed dialysate system	347	51	2.6%
2008t Hemodialysis System W/Bibag	Dialyzer, high permeability with or without sealed dialysate system	331	31	4%
2008k2 Hemodialysis Sys Olc/Dp Spanish	Dialyzer, high permeability with or without sealed dialysate system	220	2	0%
2008t Hd Sys W/O Cdx W/Bibag Blue Star	Dialyzer, high permeability with or without sealed dialysate system	212	24	2.6%
2008k Hemodialysis Sys Olc/Diasafe Plus	Dialyzer, high permeability with or without sealed dialysate system	86	0	5.4%
Crit-Line Blood Chamber	Accessories, blood circuit, hemodialysis	7	0	0%
Optiflux 160nre Dialyzer Finished Assy	Dialyzer, high permeability with or without sealed dialysate system	4	27	0.8%
Fmc Cassette	System, peritoneal, automatic delivery	1	30	1%
Liberty Cycler Set Single Conn /Ext Dl	System, peritoneal, automatic delivery	1	952	0.5%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FKX	System, peritoneal, automatic delivery	16,532	83.5%
KDI	Dialyzer, high permeability with or without sealed dialysate system	2,895	14.6%
KPO	Dialysate concentrate for hemodialysis (liquid or powder)	258	1.3%
KOC	Accessories, blood circuit, hemodialysis	57	0.3%
FKP	System, dialysate delivery, single patient	4	0%
FJK	Set, tubing, blood, with and without anti-regurgitation valve	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

Death3.8%743

Injury21.3%4,219

Malfunction74.9%14,831

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Concord Manufacturing reports

How many FDA device reports name Concord Manufacturing as manufacturer?

19,793 reports through August 2026, 5 of them in the latest 12 months.

Which of its brands appear most often?

Liberty Select Cycler Assy Non-Valuated (13,448), Liberty Cycler (1,153), 2008T HEMODIALYSIS SYS., with CDX (838), Ul Liberty Cycler Assembly Non-Valuated (723) and Liberty Select Cycler (553).

Which device types does it report on?

system, peritoneal, automatic delivery (83.5%), dialyzer, high permeability with or without sealed dialysate system (14.6%), dialysate concentrate for hemodialysis (liquid or powder) (1.3%) and accessories, blood circuit, hemodialysis (0.3%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.