Device manufacturer, as written on reports

Cordis: medical device reports filed with FDA

11,677 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.

11,677
reports naming it as manufacturer: 0% of all MAUDE reports; 212
reports, 12 months to August 2026: 1,001 in the 12 months before; 49.5%
classified as malfunction: 62.3% across all reports; 2.3%
classified as death, as reported: 0.9% across all reports

11,677 medical device reports received by FDA give Cordis as the manufacturer of the device involved, 0% of the MAUDE database, from May 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

212 reports arrived in the 12 months to August 2026, down 79% from 1,001 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 (49.5%), injury (47.2%) and death (2.3%). 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
Exoseal	Device, hemostasis, vascular	871	1,161	0%
Unknown Trapease	Filter, intravascular, cardiovascular	667	0	1.7%
Unknown Optease Vena Cava Filter	Filter, intravascular, cardiovascular	478	0	1.7%
Trapease Pvcf Fem/Jug 55cm Csi	Filter, intravascular, cardiovascular	340	0	3.7%
Cypher Sirolimus-Eluting Coronary Stent	Coronary drug-eluting stent	327	0	10.3%
Angioguard Rx Emboli Capture Guidewire System	Temporary carotid catheter for embolic capture	314	0	0.6%
Angioguard Rx	Temporary carotid catheter for embolic capture	293	38	0.5%
Angioguard Xp Emboli Capture Guidewire System	Temporary carotid catheter for embolic capture	273	0	0%
Optease Retrieval Filter	Filter, intravascular, cardiovascular	216	0	3.4%
466fxxxx	Filter, intravascular, cardiovascular	211	0	1.9%
Smart Control Nitinol Stent System	Stents, drains and dilators for the biliary ducts	206	0	1.7%
Powerflex Pro Percutaneous Transluminal Angioplasty Catheter	Catheter, angioplasty, peripheral, transluminal	151	0	0%
Saber Pta Dilatation Catheter	Catheter, angioplasty, peripheral, transluminal	149	0	0%
Cordis	Coronary drug-eluting stent	123	0	9.3%
Trapease Filter	Catheter, intravascular, diagnostic	89	0	13.9%
Unknown Vena Cava Filter	Filter, intravascular, cardiovascular	84	0	3.3%
Precise Pro Rx Carotid Stent System	Stent, carotid	52	0	15.9%
Exoseal Vascular Closure Device Vcd	Device, hemostasis, vascular	51	0	1.8%
Infiniti	Catheter, intravascular, diagnostic	41	141	0%
Unknown Trapease Vena Cava Filter	Filter, intravascular, cardiovascular	41	0	1.9%
Si Brite Tip	Introducer, catheter	35	0	2.4%
Palmaz Genesis Opta Pro	Stents, drains and dilators for the biliary ducts	27	0	0%
Outback Re-Entry Catheter	Catheter, percutaneous	26	0	0%
Si Avanti Plus	Dilator, vessel, for percutaneous catheterization	23	0	0.8%
Optease Vena Cava Filter	Filter, intravascular, cardiovascular	22	0	2.1%
466p306x	Filter, intravascular, cardiovascular	21	0	1.8%
Vista Brite Tip Guiding Catheters	Catheter, percutaneous	21	0	0%
Saber	Catheter, angioplasty, peripheral, transluminal	19	45	0%
Tempo	Implantable pacemaker pulse-generator	19	155	0.7%
Mynx Control	Device, hemostasis, vascular	18	768	0.1%

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	2,356	20.2%
LIT	Catheter, angioplasty, peripheral, transluminal	1,634	14%
MGB	Device, hemostasis, vascular	992	8.5%
NTE	Temporary carotid catheter for embolic capture	987	8.5%
FGE	Stents, drains and dilators for the biliary ducts	944	8.1%
DQX	Wire, guide, catheter	816	7%
DQO	Catheter, intravascular, diagnostic	704	6%
NIQ	Coronary drug-eluting stent	704	6%
MAF	Stent, coronary	512	4.4%
DYB	Introducer, catheter	277	2.4%

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

Death2.3%267

Injury47.2%5,508

Malfunction49.5%5,775

Other0.5%53

Not given0.6%74

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

Questions about Cordis reports

How many FDA device reports name Cordis as manufacturer?

11,677 reports through August 2026, 212 of them in the latest 12 months.

Which of its brands appear most often?

Exoseal (871), Unknown Trapease (667), Unknown Optease Vena Cava Filter (478), Trapease Pvcf Fem/Jug 55cm Csi (340) and Cypher Sirolimus-Eluting Coronary Stent (327).

Which device types does it report on?

filter, intravascular, cardiovascular (20.2%), catheter, angioplasty, peripheral, transluminal (14%), device, hemostasis, vascular (8.5%) and temporary carotid catheter for embolic capture (8.5%).

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.