Device manufacturer, as written on reports

St Paul: medical device reports filed with FDA

34,839 reports name it as the manufacturer of the device involved, 2018–2024.

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.

34,839
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 1 in the 12 months before; 99%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

34,839 medical device reports received by FDA give St Paul as the manufacturer of the device involved, 0.1% of the MAUDE database, from April 2018 to September 2024. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, against 1 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 (99%), injury (0.9%) and death (0.1%). 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	Pump, infusion	7,281	9	0.1%
Medfusion	Pump, infusion	2,731	0	0.1%
Medfusion 3500 Syringe Infusion Pump	Pump, infusion	1,766	62	0.3%
CADD-Legacy PLUS Pump	Pump, infusion	1,410	169	0%
Medfusion 4000 Syringe Infusion Pump	Pump, infusion	1,190	557	0%
Medfusion 4000 Wireless Syringe Infusion Pump	Pump, infusion	982	0	0%
Medfusion 3500 Pumps	Pump, infusion	838	0	0%
CADD Legacy Plus Pump	Pump, infusion	833	617	0%
Medfusion 4000 Pumps	Pump, infusion	716	0	0%
CADD Medication Cassette	Set, administration, intravascular	683	126	0%
Cadd Medication Cassette Reservoirs With Flow Stop	Set, administration, intravascular	669	0	0%
Cadd-Legacy Plus Ambulatory Infusion System	Pump, infusion	617	0	0%
Medfusion Model 4000 Syringe Infusion Pump	Pump, infusion	459	0	0%
Cadd Cassette Reservoirs - Flow Stop	Set, administration, intravascular	457	0	0.2%
CADD legacy 1 pump	Pump, infusion	427	23	0.2%
Cadd Administration Set With Flow Stop	Set, administration, intravascular	366	0	0.2%
Cadd Extension Sets	Set, administration, intravascular	313	1	0%
Cadd Medication Cassettes	Set, administration, intravascular	308	3	0%
Level 1	Warmer, thermal, infusion fluid	282	0	0.5%
CADD-Legacy One Ambulatory Infusion Pump	Pump, infusion	253	181	0%
Cadd Cassette Reservoirs With Flow Stop	Set, administration, intravascular	210	0	0.9%
Medfusion 3500 Pump	Pump, infusion	202	15	0%
Cadd Legacy 1 Pumps	Pump, infusion	201	0	0%
Cadd Legacy One Ambulatory Infusion Pump	Pump, infusion	197	0	0%
CADD Administration Set	Set, administration, intravascular	196	246	0%
Cadd-Legacy Plus Ambulatory Infusion Pump	Pump, infusion	195	21	0.3%
Medfusion Pump 3500	Pump, infusion	176	0	0%
CADD Extension Set	Set, administration, intravascular	173	177	0.1%
Cadd Legacy Plus	Pump, infusion	171	0	0%
Cadd Solis Vip Ambulatory Infusion Pump	Pump, infusion	162	8	0.1%

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	23,349	67%
FPA	Set, administration, intravascular	7,799	22.4%
MEA	Pump, infusion, pca	1,190	3.4%
LGZ	Warmer, thermal, infusion fluid	868	2.5%
BSB	Warmer, blood, non-electromagnetic radiation	350	1%
BTL	Ventilator, emergency, powered (resuscitator)	249	0.7%
KZL	Device, warming. blood and plasma	249	0.7%
CCK	Analyzer, gas, carbon-dioxide, gaseous-phase	187	0.5%
DQA	Oximeter	93	0.3%
LJT	Port & catheter, implanted, subcutaneous, intravascular	79	0.2%

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

Death0.1%21

Injury0.9%320

Malfunction99%34,498

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 St Paul reports

How many FDA device reports name St Paul as manufacturer?

34,839 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Cadd (7,281), Medfusion (2,731), Medfusion 3500 Syringe Infusion Pump (1,766), CADD-Legacy PLUS Pump (1,410) and Medfusion 4000 Syringe Infusion Pump (1,190).

Which device types does it report on?

pump, infusion (67%), set, administration, intravascular (22.4%), pump, infusion, pca (3.4%) and warmer, thermal, infusion fluid (2.5%).

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.