Catheter, flow directed: medical device reports filed with FDA

4,882 reports carry this product code, 1992–2026; 18 brands with a page.

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.

4,882
reports with this product code: 0% of all MAUDE reports; 351
reports, 12 months to August 2026: 253 in the 12 months before; 80.1%
classified as malfunction: 62.3% across all reports; 2.9%
classified as death, as reported: 0.9% across all reports

Product code DYG is FDA's classification for "Catheter, flow directed" (cardiovascular panel), a class 2 device. 4,882 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

351 reports arrived in the 12 months to August 2026, up 39% from 253 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 (80.1%), injury (13.1%) and death (2.9%). 18 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Swan-Ganz Continuous Cardiac Output Catheter	203	0	0%	96.6%
Swan-Ganz catheter	188	89	5.6%	78.3%
Marathon Micro Catheter	149	0	2.3%	35.5%
Swan-Ganz Ccombo V	137	88	0.6%	97%
Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion	74	2	0.4%	97.9%
Baxter	35	3	3.8%	54.2%
Swan-Ganz Bipolar Pacing Catheter For SVC Insertion	32	14	0%	92.9%
Attain	29	0	1.5%	42.9%
Abbott	7	0	7.5%	52.1%
Arrow	6	65	3.4%	66.7%
FloTrac Sensor	4	10	0%	96.9%
Apollo	3	141	1.8%	84.1%
Attain Command	3	12	4.4%	68.6%
Marathon	3	66	5.9%	54.9%
Catheter	2	9	3.7%	27.9%
Intra-Aortic Balloon Catheter	2	0	3.9%	74.4%
Unknown Catheter	2	26	2.2%	38.1%
Trek Coronary Dilatation Catheter	1	3	1.1%	83.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Edwards Lifesciences Pr	1,829	37.5%
Edwards Lifesciences	476	9.8%
Arrow International	252	5.2%
Ev3 Neurovascular	192	3.9%
Arrow Intl	189	3.9%
Abbott Laboratories	127	2.6%
B Braun Medical	84	1.7%
Icu Medical	82	1.7%
Medtronic Ireland	29	0.6%
Baxter Healthcare	22	0.5%
Hospira	22	0.5%
Teleflex	12	0.2%
Lemaitre Vascular	7	0.1%
Datascope	5	0.1%
Biosense Webster	4	0.1%

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 and report source

Event type

Death2.9%140

Injury13.1%641

Malfunction80.1%3,912

Other2.7%133

Not given1.1%56

Who filed

Manufacturer report81.3%3,968

Voluntary report6.7%327

User facility report0%0

Distributor report0.1%5

Not given11.9%582

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Pacing problem	392	8%
Material rupture	353	7.2%
Inflation problem	318	6.5%
Deflation problem	276	5.7%
Balloon rupture	238	4.9%
Incorrect measurementthe device measured wrongly	217	4.4%
Incorrect, inadequate or imprecise result or readings	199	4.1%
Breakthe device broke	184	3.8%
Leak/splashthe device leaked	158	3.2%
Balloon leak(s)	142	2.9%
Replace	142	2.9%
Fluid/blood leak	141	2.9%
Difficult to removethe device was hard to remove	117	2.4%
Measurements, inaccurate	107	2.2%
Unable to obtain readings	105	2.2%
Detachment of device component	104	2.1%
Device, removal of (non-implant)	90	1.8%
Burst container or vessel	87	1.8%
Other (for use when an appropriate device code cannot be identified)	80	1.6%
Material separation	74	1.5%

Questions about catheter, flow directed reports

What is product code DYG?

FDA's classification code for "Catheter, flow directed", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,882 reports through August 2026, 351 of them in the latest 12 months.

Which brands appear most often?

Swan-Ganz Continuous Cardiac Output Catheter (203), Swan-Ganz catheter (188), Marathon Micro Catheter (149), Swan-Ganz Ccombo V (137) and Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion (74). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.