Device manufacturer, as written on reports

Arrow Intl: medical device reports filed with FDA

8,526 reports name it as the manufacturer of the device involved, 1993–2015.

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.

8,526
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 61.5%
classified as malfunction: 62.3% across all reports; 2.5%
classified as death, as reported: 0.9% across all reports

8,526 medical device reports received by FDA give Arrow Intl as the manufacturer of the device involved, 0% of the MAUDE database, from September 1993 to August 2015. 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, and none 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 (61.5%), injury (35.4%) and death (2.5%). 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
Iab 8 Fr - 40 Cc Fos	System, balloon, intra-aortic and control	616	0	2.6%
Autocat2 Wave	System, balloon, intra-aortic and control	462	0	1.4%
Iab 8 Fr - 40 Cc	System, balloon, intra-aortic and control	411	0	3.6%
Iab 7 5 Fr - 40 Cc	System, balloon, intra-aortic and control	331	0	4.7%
Arrow/Kontron 8fr Intra-Aortic Balloon	System, balloon, intra-aortic and control	299	0	1.2%
Iab 8 Fr - 30 Cc Fos	System, balloon, intra-aortic and control	172	0	3.1%
Arrow 8 Fr 40cc Intra-Aortic Balloon	System, balloon, intra-aortic and control	169	0	1.1%
Iab 7 5 Fr - 30 Cc	System, balloon, intra-aortic and control	110	0	2.4%
Iab 8 Fr - 30 Cc	System, balloon, intra-aortic and control	106	0	1.2%
Arrow/Kontron 9fr Intra-Aortic Balloon	System, balloon, intra-aortic and control	104	0	1%
Epidural Catheterization Kit	Catheter, conduction, anesthetic	98	3	0%
Arrow Epidural Anesthesia Kit	Anesthesia conduction kit	70	12	0%
Arrow	System, balloon, intra-aortic and control	58	65	3.4%
Arrow Epidural Catheterization Kit	Anesthesia conduction kit	37	15	0%
Cvc Set 3-Lumen 7 Fr X 20 Cm	Catheter, percutaneous	20	0	0%
Cvc Set 2-Lumen 7 Fr X 20 Cm	Catheter, intravascular, therapeutic, short-term less than 30 days	9	0	0.4%
Epidural Catheterization Set	Anesthesia conduction kit	4	29	0%
Arrow Epidural Catheterization Set	Catheter, conduction, anesthetic	3	80	0%
Catheter	Pump, infusion, implanted, programmable	2	9	3.7%
Intra-Aortic Balloon Catheter	System, balloon, intra-aortic and control	2	0	3.9%

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
DSP	System, balloon, intra-aortic and control	4,447	52.2%
DQO	Catheter, intravascular, diagnostic	800	9.4%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	656	7.7%
CAZ	Anesthesia conduction kit	430	5%
DYB	Introducer, catheter	286	3.4%
DQY	Catheter, percutaneous	281	3.3%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	224	2.6%
DYG	Catheter, flow directed	189	2.2%
DXE	Catheter, embolectomy	175	2.1%
MSD	Catheter, hemodialysis, implanted	162	1.9%

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

Death2.5%213

Injury35.4%3,015

Malfunction61.5%5,241

Other0.3%26

Not given0.4%31

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

Questions about Arrow Intl reports

How many FDA device reports name Arrow Intl as manufacturer?

8,526 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Iab 8 Fr - 40 Cc Fos (616), Autocat2 Wave (462), Iab 8 Fr - 40 Cc (411), Iab 7 5 Fr - 40 Cc (331) and Arrow/Kontron 8fr Intra-Aortic Balloon (299).

Which device types does it report on?

system, balloon, intra-aortic and control (52.2%), catheter, intravascular, diagnostic (9.4%), catheter, intravascular, therapeutic, short-term less than 30 days (7.7%) and anesthesia conduction kit (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.