Device manufacturer, as written on reports

Cook Ireland: medical device reports filed with FDA

9,278 reports name it as the manufacturer of the device involved, 2008–2026.

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.

9,278
reports naming it as manufacturer: 0% of all MAUDE reports; 587
reports, 12 months to August 2026: 762 in the 12 months before; 63.1%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

9,278 medical device reports received by FDA give Cook Ireland as the manufacturer of the device involved, 0% of the MAUDE database, from May 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

587 reports arrived in the 12 months to August 2026, down 23% from 762 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 (63.1%), injury (36.6%) and death (0.3%). 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
Zilver Ptx Drug-Eluting Peripheral Stent	Stent, superficial femoral artery, drug-eluting	723	9	0%
Zimmon Biliary Stent	Stents, drains and dilators for the biliary ducts	657	45	0%
Evolution Biliary Controlled-Release Stent - Fully Covered	Stents, drains and dilators for the biliary ducts	586	99	0.2%
Zilver Ptx 35 Drug-Eluting Stent	Stent, superficial femoral artery, drug-eluting	581	16	0.7%
Echotip Ultra Endoscopic Ultrasound Needle	Biopsy needle	571	49	0%
Echotip Procore High Definition Ultrasound Biopsy Needle	Biopsy needle	544	27	0%
Zimmon Biliary Stent Set	Stents, drains and dilators for the biliary ducts	526	34	0%
Zilver 635 Biliary Self Expanding Metal Stent	Stents, drains and dilators for the biliary ducts	352	13	0%
EchoTip ProCore Endobronchial HD Biopsy Needle	Biopsy needle	295	40	0%
Cotton-Leung Biliary Stent	Stents, drains and dilators for the biliary ducts	260	20	1.1%
Resonance Stent Set	Stent, ureteral	254	16	1.2%
Zimmon Pancreatic Stent	Stents, drains and dilators for the biliary ducts	208	6	0%
Zilver Vena Venous Self-Expanding Stent	Stent, iliac vein	198	9	0%
Evolution Duodenal Controlled-Release Stent - Uncovered	Stent, metallic, expandable, duodenal	197	5	0.5%
Zilver Flex 35 Vascular Self-Expanding Stent	Stent, iliac	195	23	0.5%
Evolution Biliary Controlled-Release Stent - Uncovered	Stents, drains and dilators for the biliary ducts	193	20	0%
Echotip Ultra Endobronchial Hd Ultrasound Needle	Biopsy needle	191	24	0%
Evolution Esophageal Controlled-Release Stent - Partially Covered	Prosthesis, esophageal	152	6	0.6%
Evolution Colonic Controlled-Release Stent - Uncovered	Stent, colonic, metallic, expandable	142	5	0.7%

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
FGE	Stents, drains and dilators for the biliary ducts	3,920	42.3%
FCG	Biopsy needle	1,806	19.5%
NIU	Stent, superficial femoral artery, drug-eluting	1,416	15.3%
NIO	Stent, iliac	453	4.9%
ESW	Prosthesis, esophageal	418	4.5%
FAD	Stent, ureteral	288	3.1%
QAN	Stent, iliac vein	240	2.6%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	199	2.1%
MUM	Stent, metallic, expandable, duodenal	199	2.1%
MQR	Stent, colonic, metallic, expandable	153	1.6%

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

Death0.3%25

Injury36.6%3,397

Malfunction63.1%5,852

Other0%0

Not given0%4

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

Questions about Cook Ireland reports

How many FDA device reports name Cook Ireland as manufacturer?

9,278 reports through August 2026, 587 of them in the latest 12 months.

Which of its brands appear most often?

Zilver Ptx Drug-Eluting Peripheral Stent (723), Zimmon Biliary Stent (657), Evolution Biliary Controlled-Release Stent - Fully Covered (586), Zilver Ptx 35 Drug-Eluting Stent (581) and Echotip Ultra Endoscopic Ultrasound Needle (571).

Which device types does it report on?

stents, drains and dilators for the biliary ducts (42.3%), biopsy needle (19.5%), stent, superficial femoral artery, drug-eluting (15.3%) and stent, iliac (4.9%).

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.