Device manufacturer, as written on reports

Cardinal Health: medical device reports filed with FDA

6,050 reports name it as the manufacturer of the device involved, 2002–2026.

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.

6,050
reports naming it as manufacturer: 0% of all MAUDE reports; 200
reports, 12 months to August 2026: 446 in the 12 months before; 72.3%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

6,050 medical device reports received by FDA give Cardinal Health as the manufacturer of the device involved, 0% of the MAUDE database, from January 2002 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

200 reports arrived in the 12 months to August 2026, down 55% from 446 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 (72.3%), injury (18.5%) and other (7.1%). 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
Mynxgrip 6f/7f Vascular Closure Device	Device, hemostasis, vascular	606	0	0.8%
Mynxgrip 5f Vascular Closure Device	Device, hemostasis, vascular	260	0	0%
Kangaroo	Pump, infusion, enteral	233	117	0.2%
Argyle	Catheter, peritoneal, long-term indwelling	155	60	1%
Magellan	Needle, hypodermic, single lumen	134	20	0%
Mynx Ace 6f/7f Vascular Closure Device	Device, hemostasis, vascular	84	0	0.6%
Dover	Catheter, urological	82	32	0.6%
Monoject	Syringe, piston	57	14	0.2%
Cardinal Health	Tubes, gastrointestinal (and accessories)	52	185	0.2%
Covidien	Mesh, surgical, polymeric	41	30	1.4%
Mynx Vascular Closure Device	Device, hemostasis, vascular	39	0	1.5%
Epump 1000ml Safety Screw Spik	Pump, infusion, enteral	32	0	0%
Vistec	Gauze/sponge, internal, x-ray detectable	22	29	0%
Alaris	Pump, infusion	17	79	1.1%
Kangaroo Joeypump W/Pole Clmp	Pump, infusion, enteral	12	0	0%
AirLife	Ventilator, emergency, manual (resuscitator)	10	37	2.6%
Kendall	Electrode, electrocardiograph	7	23	2.3%
Genesis	Implant, endosseous, root-form	3	0	0.1%
Mynxgrip Vascular Closure Device 5f	Device, hemostasis, vascular	3	0	0%
Ni	Set, administration, for peritoneal dialysis, disposable	3	1,587	1.8%
Latex Exam Gloves	Latex patient examination glove	2	0	0.1%
Mynxgrip	Device, hemostasis, vascular	2	422	0.3%
Smartsite Infusion Set	Set, administration, intravascular	2	0	0.5%
Viasys	Ventilator, continuous, facility use	2	0	6%
2 5mm Drill Bit/Qc/Gold/110mm	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	1	14	0%
3 5fr Urethane Umb Cath	Catheter, umbilical artery	1	0	0.8%
Alaris Pump Module	Pump, infusion	1	0	0%
Curity	Tube, tracheal (w/wo connector)	1	18	0.2%
Esteem	—	1	12	0%

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
MGB	Device, hemostasis, vascular	1,136	18.8%
KNT	Tubes, gastrointestinal (and accessories)	955	15.8%
FMI	Needle, hypodermic, single lumen	316	5.2%
LZH	Pump, infusion, enteral	276	4.6%
GCY	Apparatus, suction, single patient use, portable, nonpowered	231	3.8%
FMF	Syringe, piston	174	2.9%
PIF	Gastrointestinal tubes with enteral specific connectors	143	2.4%
KOD	Catheter, urological	107	1.8%
KGO	Surgeon's gloves	105	1.7%
GDY	Gauze/sponge, internal, x-ray detectable	101	1.7%

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

Death1%61

Injury18.5%1,120

Malfunction72.3%4,375

Other7.1%428

Not given1.1%66

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

Questions about Cardinal Health reports

How many FDA device reports name Cardinal Health as manufacturer?

6,050 reports through August 2026, 200 of them in the latest 12 months.

Which of its brands appear most often?

Mynxgrip 6f/7f Vascular Closure Device (606), Mynxgrip 5f Vascular Closure Device (260), Kangaroo (233), Argyle (155) and Magellan (134).

Which device types does it report on?

device, hemostasis, vascular (18.8%), tubes, gastrointestinal (and accessories) (15.8%), needle, hypodermic, single lumen (5.2%) and pump, infusion, enteral (4.6%).

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.