Catheter, cannula and tubing, vascular, cardiopulmonary bypass: medical device reports filed with FDA

6,314 reports carry this product code, 1992–2026; 22 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.

6,314
reports with this product code: 0% of all MAUDE reports; 1,194
reports, 12 months to August 2026: 819 in the 12 months before; 73%
classified as malfunction: 62.3% across all reports; 4.8%
classified as death, as reported: 0.9% across all reports

Product code DWF is FDA's classification for "Catheter, cannula and tubing, vascular, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 6,314 medical device reports carry this product code, 0% of the MAUDE database, from February 1992 to August 2026.

1,194 reports arrived in the 12 months to August 2026, up 46% from 819 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 (73%), injury (19.9%) and death (4.8%). 22 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
Custom Tubing Pack	469	353	1.1%	95.2%
EOPA Arterial Cannula	262	100	1.1%	90.1%
Cannula 77010 Art One Piece 10fr	211	160	0%	100%
Endoplege Coronary Sinus Catheter	193	0	0.4%	85%
Cardiovascular Procedure Kit	102	0	1.3%	82.6%
Endoclamp Aortic Catheter	23	0	2.4%	72.8%
Fogarty Arterial Embolectomy Catheter	6	37	0.2%	87.4%
Arctic Sun 5000	5	1,032	0%	95.4%
Catheter	5	9	3.7%	27.9%
Tubing Set	5	104	14%	74.4%
Terumo Cardiovascular Procedure Kit	4	24	0.7%	80%
Terumo	2	0	2.8%	12.2%
Unknown ArcticGel Pads	2	20	0%	90.5%
Argyle	1	60	1%	82.4%
Artic Sun 5000 115v Na	1	0	0%	89.6%
Codman	1	0	1.6%	57.9%
Custom Combi Set	1	15	3.8%	87.1%
Lifeport Vascular Access System	1	0	0.5%	17.7%
Medtronic	1	17	4.4%	23.5%
Quantum	1	35	0.5%	66.7%
Stopcock	1	16	0%	90.2%
V-Cath	1	0	1.7%	14.3%

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
Perfusion Systems	1,425	22.6%
Edwards Lifesciences	926	14.7%
Medtronic Mexico S De R L De Cv	561	8.9%
Maquet Cardiopulmonary	439	7%
Medtronic Mexico	281	4.5%
Medtronic Perfusion Systems	276	4.4%
Terumo Cardiovascular Systems	274	4.3%
Datascope	90	1.4%
Ethicon	82	1.3%
Angiodynamics	77	1.2%
Livanova USA	77	1.2%
Livanova Deutschland	55	0.9%
Sorin Group Italia	30	0.5%
Quest Medical	20	0.3%
Terumo Cardiovascular System	17	0.3%

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

Death4.8%301

Injury19.9%1,254

Malfunction73%4,610

Other1.2%76

Not given1.2%73

Who filed

Manufacturer report92.9%5,864

Voluntary report2.1%130

User facility report0%0

Distributor report1%65

Not given4%255

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

Device problems coded

Device problem (FDA code)	Reports	Share
Material separation	678	10.7%
Fluid/blood leak	574	9.1%
Material deformation	457	7.2%
Mechanical problema mechanical problem	426	6.7%
Leak/splashthe device leaked	354	5.6%
Material puncture/hole	334	5.3%
Crackthe device cracked	332	5.3%
Breakthe device broke	271	4.3%
Delivered as unsterile product	270	4.3%
Replace	192	3%
Contamination	182	2.9%
Obstruction of flow	177	2.8%
Detachment of device component	133	2.1%
Difficult to removethe device was hard to remove	108	1.7%
Disconnection	104	1.6%
Fracturea broken bone	100	1.6%
Difficult to insertthe device was hard to insert	99	1.6%
Detachment of device or device componentpart of the device came off	87	1.4%
Insufficient device problem information	82	1.3%
Material integrity problema problem with the device material	77	1.2%

Questions about catheter, cannula and tubing, vascular, cardiopulmonary bypass reports

What is product code DWF?

FDA's classification code for "Catheter, cannula and tubing, vascular, cardiopulmonary bypass", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,314 reports through August 2026, 1,194 of them in the latest 12 months.

Which brands appear most often?

Custom Tubing Pack (469), EOPA Arterial Cannula (262), Cannula 77010 Art One Piece 10fr (211), Endoplege Coronary Sinus Catheter (193) and Cardiovascular Procedure Kit (102). 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.