Device manufacturer, as written on reports

Cook: medical device reports filed with FDA

36,416 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.

36,416
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,543
reports, 12 months to August 2026: 1,745 in the 12 months before; 51.8%
classified as malfunction: 62.3% across all reports; 1.7%
classified as death, as reported: 0.9% across all reports

36,416 medical device reports received by FDA give Cook as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,543 reports arrived in the 12 months to August 2026, down 12% from 1,745 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 (51.8%), injury (45.7%) and death (1.7%). 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
Gunther Tulip Femoral Vena Cava Filter Set	Filter, intravascular, cardiovascular	1,846	0	0.6%
NCircle Tipless Stone Extractor	Dislodger, stone, basket, ureteral, metal	1,424	232	0%
Ngage Nitinol Stone Extractor	Dislodger, stone, basket, ureteral, metal	1,180	1	0%
Gunther Tulip Jugular Vena Cava Filter Set	Filter, intravascular, cardiovascular	1,163	0	0.7%
Zenith Flex AAA Endovascular Graft Bifurcated Main Body	System, endovascular graft, aortic aneurysm treatment	1,153	15	6.1%
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter	Catheter, nephrostomy, general & plastic surgery	883	58	0%
Zenith Flex with Spiral-Z Technology AAA Endovascular Graft Iliac Leg	System, endovascular graft, aortic aneurysm treatment	719	91	3.6%
Ultrathane Dawson-Mueller Mac-Loc Locking Loop Multipurpose Drainage Catheter	Catheter, nephrostomy, general & plastic surgery	676	37	0.3%
Flexor Ansel Guiding Sheath	Introducer, catheter	569	26	0.5%
Advance 35 Lp Low Profile Balloon Catheter	Catheter, percutaneous	566	15	0.5%
Zenith Aaa Iliac Leg Graft	System, endovascular graft, aortic aneurysm treatment	550	0	1.8%
Flexor Raabe Guiding Sheath	Introducer, catheter	535	30	1.1%
Bakri Tamponade Balloon Catheter	Intrauterine tamponade balloon	469	34	0%
Zenith Aaa Main Body Graft	System, endovascular graft, aortic aneurysm treatment	468	0	3.2%
Performer Introducer	Introducer, catheter	464	15	1.3%
Micropuncture Transitionless Stiffened Cannula Access Set	Introducer, catheter	401	19	0%
Cxi Support Catheter	Catheter, continuous flush	400	23	0%
Flexor High-Flex Ansel Guiding Sheath	Introducer, catheter	399	19	0.5%
Micropuncture Transitionless Access Set	Introducer, catheter	380	19	0.3%
Zenith Aaa Endovascular Graft Iliac Leg	System, endovascular graft, aortic aneurysm treatment	337	0	2.5%
Cook Bakri Postpartum Balloon with Rapid Instillation Components	Intrauterine tamponade balloon	331	52	0.3%
Zenith Aaa Endovascular Graft Bifurcated Main Body	System, endovascular graft, aortic aneurysm treatment	278	0	3.5%
Zenith Flex Aaa Endovascular Graft Iliac Leg	System, endovascular graft, aortic aneurysm treatment	267	1	3.7%
Ncircle Delta Wire Tipless Stone Extractor	Dislodger, stone, basket, ureteral, metal	263	28	0%
Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter	Biliary catheter for stone removal that may also allow for irrigation and contrast injection	224	7	1.2%
Cook Single-Use Holmium Laser Fiber	Powered laser surgical instrument	197	3	0%
Filiform Double Pigtail Ureteral Stent Set	Stent, ureteral	191	38	0.4%
Advance 14 Lp Low Profile Balloon Catheter	Catheter, angioplasty, peripheral, transluminal	186	4	0%
Advance 18 Lp Low Profile Balloon Catheter	Catheter, angioplasty, peripheral, transluminal	175	8	0.5%
Retracta Detachable Embolization Coil	Device, vascular, for promoting embolization	160	20	0.9%

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
DTK	Filter, intravascular, cardiovascular	5,506	15.1%
MIH	System, endovascular graft, aortic aneurysm treatment	4,899	13.5%
DYB	Introducer, catheter	4,683	12.9%
FFL	Dislodger, stone, basket, ureteral, metal	3,305	9.1%
DQY	Catheter, percutaneous	1,570	4.3%
GBO	Catheter, nephrostomy, general & plastic surgery	1,465	4%
DQX	Wire, guide, catheter	1,247	3.4%
DQO	Catheter, intravascular, diagnostic	916	2.5%
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	873	2.4%
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	793	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

Death1.7%631

Injury45.7%16,638

Malfunction51.8%18,864

Other0.6%219

Not given0.2%64

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

Questions about Cook reports

How many FDA device reports name Cook as manufacturer?

36,416 reports through August 2026, 1,543 of them in the latest 12 months.

Which of its brands appear most often?

Gunther Tulip Femoral Vena Cava Filter Set (1,846), NCircle Tipless Stone Extractor (1,424), Ngage Nitinol Stone Extractor (1,180), Gunther Tulip Jugular Vena Cava Filter Set (1,163) and Zenith Flex AAA Endovascular Graft Bifurcated Main Body (1,153).

Which device types does it report on?

filter, intravascular, cardiovascular (15.1%), system, endovascular graft, aortic aneurysm treatment (13.5%), introducer, catheter (12.9%) and dislodger, stone, basket, ureteral, metal (9.1%).

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.