Oxygenator, cardiopulmonary bypass: medical device reports filed with FDA

10,703 reports carry this product code, 1992–2026; 21 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.

10,703
reports with this product code: 0% of all MAUDE reports; 1,751
reports, 12 months to August 2026: 742 in the 12 months before; 78.2%
classified as malfunction: 62.3% across all reports; 4.2%
classified as death, as reported: 0.9% across all reports

Product code DTZ is FDA's classification for "Oxygenator, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 10,703 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to August 2026.

1,751 reports arrived in the 12 months to August 2026, up 136% from 742 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 (78.2%), injury (14.5%) and death (4.2%). 21 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
Fusion Hollow Fiber Oxygenator	1,515	996	0.7%	95.4%
Capiox Fx Oxygenator	408	0	1.5%	74.6%
Tubing Set	302	104	14%	74.4%
Sterile Fx25rwc W/ Res	279	0	2.5%	92.5%
Sterile Fx25rec W/Res	277	0	1.4%	92.1%
Affinity Nt Balance	271	150	0.4%	95.2%
Oxygenator Cardiopulmonary Bypass	271	0	4.7%	83.9%
Hls Set Advanced	214	0	12.1%	84.7%
Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.	160	68	6.3%	89.4%
Hlm Tubing Set W/Bioline Coating	139	0	7.1%	70.6%
Navilyst Medical	7	0	0.4%	90.9%
Cardiovascular Procedure Kit	6	0	1.3%	82.6%
Shunt Sensor Sys500	5	0	0.1%	71.3%
AngioDynamics	4	14	1.7%	82.2%
Heart Lung Machine	3	283	3.7%	95.4%
Apex	1	78	1.3%	86.8%
Custom Tubing Pack	1	353	1.1%	95.2%
Gunther Tulip Vena Cava Filter Retrieval Set	1	10	0.4%	76.1%
Medtronic	1	17	4.4%	23.5%
Reservoir	1	0	0.2%	54.4%
Terumo	1	0	2.8%	12.2%

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	2,357	22%
Maquet Cardiopulmonary	2,068	19.3%
Terumo Cardiovascular Systems	1,995	18.6%
Terumo Ashitaka	1,485	13.9%
Medtronic Perfusion Systems	540	5%
Sorin Group Italia	461	4.3%
Terumo Medical	126	1.2%
Terumo	78	0.7%
Datascope	28	0.3%
Thoratec	27	0.3%
Maquet	18	0.2%
Abiomed	12	0.1%
Terumo Cardiovascular System	10	0.1%
Maquet Cardiovascular	9	0.1%
Thoratec Switzerland	6	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

Death4.2%453

Injury14.5%1,553

Malfunction78.2%8,366

Other1.9%202

Not given1.2%129

Who filed

Manufacturer report93.3%9,983

Voluntary report1.3%135

User facility report0%0

Distributor report2.7%290

Not given2.8%295

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	2,552	23.8%
Leak/splashthe device leaked	1,796	16.8%
Increase in pressure	753	7%
Replace	693	6.5%
Gas output problem	359	3.4%
Breakthe device broke	353	3.3%
Pressure problem	296	2.8%
Crackthe device cracked	280	2.6%
Infusion or flow problema problem with flow or infusion	266	2.5%
Obstruction of flow	258	2.4%
Device operates differently than expectedthe device behaved unexpectedly	231	2.2%
Material separation	172	1.6%
Malfunction	171	1.6%
Poor gas exchange	167	1.6%
Device damaged prior to usethe device was damaged before use	165	1.5%
Air/gas in device	153	1.4%
Other (for use when an appropriate device code cannot be identified)	151	1.4%
Device issuea problem with the device	140	1.3%
Packaging problem	136	1.3%
Coagulation in device or device ingredient	129	1.2%

Questions about oxygenator, cardiopulmonary bypass reports

What is product code DTZ?

FDA's classification code for "Oxygenator, 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?

10,703 reports through August 2026, 1,751 of them in the latest 12 months.

Which brands appear most often?

Fusion Hollow Fiber Oxygenator (1,515), Capiox Fx Oxygenator (408), Tubing Set (302), Sterile Fx25rwc W/ Res (279) and Sterile Fx25rec W/Res (277). 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.