Device manufacturer, as written on reports

Icu Medical: medical device reports filed with FDA

16,487 reports name it as the manufacturer of the device involved, 1992–2026.

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.

16,487
reports naming it as manufacturer: 0.1% of all MAUDE reports; 9,103
reports, 12 months to August 2026: 4,787 in the 12 months before; 95.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

16,487 medical device reports received by FDA give Icu Medical as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9,103 reports arrived in the 12 months to August 2026, up 90% from 4,787 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 (95.4%), injury (2.3%) and other (1.6%). 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
CADD-Solis VIP Ambulatory Infusion Pump	Pump, infusion	4,982	3,471	0.1%
CADD Solis HPCA Pump	Pump, infusion, pca	1,478	1,183	0.1%
CADD Legacy Plus Pump	Pump, infusion	820	617	0%
Medfusion 4000 Syringe Infusion Pump	Pump, infusion	721	557	0%
Pump Infusion	Pump, infusion	654	5	0%
CADD-Legacy One Ambulatory Infusion Pump	Pump, infusion	303	181	0%
CADD-Solis HPCA Pump	Pump, infusion, pca	295	224	0%
CADD Solis VIP Pump	Pump, infusion	292	235	0.1%
ICU Medical	Set, administration, intravascular	281	55	0.3%
CADD-Solis Ambulatory Infusion Pump	Pump, infusion, pca	219	151	0.3%
Medfusion 4000 Pump	Pump, infusion	204	151	0%
CADD-Legacy PLUS Pump	Pump, infusion	182	169	0%
CADD Solis HPCA Pumps	Pump, infusion, pca	167	145	0%
CADD Legacy PCA Pumps	Pump, infusion, pca	162	116	0%
Tego Connector	Set, administration, intravascular	161	212	0.3%
Infusion Pump	Pump, infusion, implanted, programmable	128	6	3.7%
CADD Cleo Infusion Set	Set, administration, intravascular	122	1,994	0%
CADD-Solis HPCA Ambulatory Infusion Pump	Pump, infusion, pca	116	85	0%
Medfusion 3500 Syringe Infusion Pump	Pump, infusion	91	62	0.3%
CADD Extension Set	Set, administration, intravascular	83	177	0.1%
CADD Legacy PCA Pump	Pump, infusion, pca	73	71	0%
Cadd-Legacy Plus Ambulatory Infusion Pump	Pump, infusion	61	21	0.3%
CADD-Solis HCPA Pump	Pump, infusion, pca	56	33	0%
CADD Medication Cassette Reservoir	Set, administration, intravascular	55	353	0%
CADD Administration Set	Set, administration, intravascular	51	246	0%
Level 1 Fast Flow Fluid Warmer	Warmer, blood, non-electromagnetic radiation	42	29	0.8%
CADD Medication Cassette	Set, administration, intravascular	41	126	0%
Level 1 Hotline Blood And Fluid Warmer	Warmer, thermal, infusion fluid	40	17	0%
Jelco	Catheter, intravascular, therapeutic, short-term less than 30 days	32	34	0%
MicroClave Clear Connector	Set, administration, intravascular	23	25	1.9%

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
FRN	Pump, infusion	9,080	55.1%
MEA	Pump, infusion, pca	2,658	16.1%
FPA	Set, administration, intravascular	2,389	14.5%
FMG	Stopcock, i.v. set	328	2%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	270	1.6%
DRS	Transducer, blood-pressure, extravascular	269	1.6%
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	170	1%
JOH	Tube tracheostomy and tube cuff	163	1%
JKA	Tubes, vials, systems, serum separators, blood collection	115	0.7%
LGZ	Warmer, thermal, infusion fluid	102	0.6%

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

Death0.2%38

Injury2.3%387

Malfunction95.4%15,723

Other1.6%258

Not given0.5%81

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

Questions about Icu Medical reports

How many FDA device reports name Icu Medical as manufacturer?

16,487 reports through August 2026, 9,103 of them in the latest 12 months.

Which of its brands appear most often?

CADD-Solis VIP Ambulatory Infusion Pump (4,982), CADD Solis HPCA Pump (1,478), CADD Legacy Plus Pump (820), Medfusion 4000 Syringe Infusion Pump (721) and Pump Infusion (654).

Which device types does it report on?

pump, infusion (55.1%), pump, infusion, pca (16.1%), set, administration, intravascular (14.5%) and stopcock, i.v. set (2%).

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.