Device manufacturer, as written on reports

Arrow International: medical device reports filed with FDA

35,068 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.

35,068
reports naming it as manufacturer: 0.1% of all MAUDE reports; 3,467
reports, 12 months to August 2026: 3,254 in the 12 months before; 88%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

35,068 medical device reports received by FDA give Arrow International as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

3,467 reports arrived in the 12 months to August 2026, close to the 3,254 of 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 (88%), injury (10.9%) and death (0.9%). 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
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm	Catheter, percutaneous	1,386	170	0.1%
Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm	Catheter, intravascular, therapeutic, short-term less than 30 days	1,065	123	0.1%
Epidural Catheterization Kit	Catheter, conduction, anesthetic	1,060	3	0%
Autocat2 Wave	System, balloon, intra-aortic and control	856	0	1.4%
Arrow UltraFlex IAB: 7.5Fr 40cc	System, balloon, intra-aortic and control	712	243	0.1%
Fiberoptix Ultra 8 Iab 8fr 40cc	System, balloon, intra-aortic and control	649	4	1.7%
Ac3 Optimus Iabp Na/Emea	System, balloon, intra-aortic and control	639	5	0%
Arrow AC3 Optimus IABP NA/EMEA	System, balloon, intra-aortic and control	530	306	0.4%
Arrow Cvc Set 16 Ga X 8 20 Cm	Catheter, percutaneous	525	0	0%
Epidural Catheterization Set	Anesthesia conduction kit	427	29	0%
Arrow Hemodialysis Set 2-Lumen 12 Fr X 20 Cm	Catheter, subclavian	389	68	0.2%
Ultraflex Iab 7 5fr 40cc	System, balloon, intra-aortic and control	362	0	2.2%
Rediguard Iab 8fr 40cc	System, balloon, intra-aortic and control	360	0	0.8%
Arrow Ra Cath Set 22 Ga X 1-3/8	Wire, guide, catheter	306	0	0%
Arrow Arterial Cath Set 20 Ga X 8cm	Catheter, percutaneous	289	61	0%
Arrow Cath-Lab Sheath Intro Set	Catheter, percutaneous	289	23	0%
Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm	Catheter, intravascular, therapeutic, short-term less than 30 days	283	12	0%
Iab 8 Fr - 40 Cc Fos	System, balloon, intra-aortic and control	283	0	2.6%
Arrow RediGuard IAB: 8Fr 40cc	System, balloon, intra-aortic and control	267	161	0.4%
Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb	Catheter, intravascular, therapeutic, short-term less than 30 days	265	63	1%
Arrow/Kontron 8fr Intra-Aortic Balloon	System, balloon, intra-aortic and control	263	0	1.2%
Arrow Ra Cath Set 20 Ga X 1-3/4	Wire, guide, catheter	251	0	0%
Arrow Hemodialysis Kit 2-L 15 Fr X 19 Cm	Catheter, hemodialysis, implanted	242	40	0.4%
Arrow Cvc Set 3-Lumen 7fr X 20cm	Catheter, intravascular, therapeutic, short-term less than 30 days	241	30	0.4%
Cvc Set 3-Lumen 7 Fr X 20 Cm	Catheter, percutaneous	230	0	0%
Arrow UltraFlex IAB: 7.5Fr 30cc	System, balloon, intra-aortic and control	220	85	0%
Cvc Set 2-Lumen 7 Fr X 20 Cm	Catheter, intravascular, therapeutic, short-term less than 30 days	216	0	0.4%
Arrow Arterial Cath Set 20 Ga X 5cm	Catheter, percutaneous	192	74	0%
Arrow FIBEROPTIX ULTRA 8 IAB SC: 8FR 40CC	System, balloon, intra-aortic and control	190	148	0%
Arrow	System, balloon, intra-aortic and control	186	65	3.4%

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	8,862	25.3%
DQY	Catheter, percutaneous	7,296	20.8%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	5,666	16.2%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	2,289	6.5%
DQX	Wire, guide, catheter	1,639	4.7%
BSO	Catheter, conduction, anesthetic	1,294	3.7%
CAZ	Anesthesia conduction kit	1,224	3.5%
DYB	Introducer, catheter	1,189	3.4%
DQO	Catheter, intravascular, diagnostic	857	2.4%
MSD	Catheter, hemodialysis, implanted	760	2.2%

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

Death0.9%314

Injury10.9%3,817

Malfunction88%30,850

Other0.1%36

Not given0.1%51

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

Questions about Arrow International reports

How many FDA device reports name Arrow International as manufacturer?

35,068 reports through August 2026, 3,467 of them in the latest 12 months.

Which of its brands appear most often?

Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm (1,386), Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm (1,065), Epidural Catheterization Kit (1,060), Autocat2 Wave (856) and Arrow UltraFlex IAB: 7.5Fr 40cc (712).

Which device types does it report on?

system, balloon, intra-aortic and control (25.3%), catheter, percutaneous (20.8%), catheter, intravascular, therapeutic, short-term less than 30 days (16.2%) and catheter, intravascular, therapeutic, long-term greater than 30 days (6.5%).

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.