Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass: medical device reports filed with FDA

2,159 reports carry this product code, 1993–2026; 16 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.

2,159
reports with this product code: 0% of all MAUDE reports; 131
reports, 12 months to August 2026: 209 in the 12 months before; 90.7%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

Product code DTL is FDA's classification for "Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass" (cardiovascular panel), a class 2 device. 2,159 medical device reports carry this product code, 0% of the MAUDE database, from October 1993 to August 2026.

131 reports arrived in the 12 months to August 2026, down 37% from 209 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 (90.7%), injury (6.8%) and other (1.1%). 16 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
Copilot	226	26	0%	99.1%
Copilot Bleedback Control Valve	215	0	0%	93.5%
Merit Custom Kit	78	13	0.1%	96.7%
Boston Scientific	63	5	3.3%	55%
Navilyst Medical	36	0	0.4%	90.9%
Indeflator	23	23	0%	99.7%
AngioDynamics	18	14	1.7%	82.2%
Custom Tubing Pack	14	353	1.1%	95.2%
Deroyal	4	14	0.7%	72.7%
Attain	3	0	1.5%	42.9%
Cardiovascular Procedure Kit	2	0	1.3%	82.6%
Acist	1	14	10.6%	14.9%
Bulk Non Ster Xcoat Delph Pump	1	0	0.4%	97%
Hlm Tubing Set W/Bioline Coating	1	0	7.1%	70.6%
Medex	1	8	0%	81.7%
Stopcock	1	16	0%	90.2%

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
Merit Medical Systems	366	17%
Abbott Vascular	219	10.1%
Terumo Cardiovascular Systems	195	9%
Deroyal Industries	33	1.5%
Angiodynamics	18	0.8%
Vascular Solutions	18	0.8%
Datascope	11	0.5%
Guidant Vascular Intervention	7	0.3%
Livanova USA	5	0.2%
Medex	5	0.2%
Argon Medical Devices	4	0.2%
3m Health Care	3	0.1%
Medtronic Perfusion Systems	3	0.1%
Abbott	2	0.1%
Abbott Vascular-Cardiac Therapies	2	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

Death0.8%18

Injury6.8%147

Malfunction90.7%1,959

Other1.1%23

Not given0.6%12

Who filed

Manufacturer report95.7%2,066

Voluntary report1.3%28

User facility report0%0

Distributor report0.2%5

Not given2.8%60

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	719	33.3%
Breakthe device broke	266	12.3%
Loose or intermittent connection	186	8.6%
Human-device interface problem	123	5.7%
Air leak	117	5.4%
Fluid/blood leak	77	3.6%
Air/gas in device	61	2.8%
Detachment of device component	59	2.7%
Crackthe device cracked	50	2.3%
Bubble(s)	41	1.9%
Hole in material	33	1.5%
Burst container or vessel	29	1.3%
Tear, rip or hole in device packaging	26	1.2%
Defective devicethe device was defective	23	1.1%
Device contamination with chemical or other material	23	1.1%
Improper or incorrect procedure or method	21	1%
Physical resistance/sticking	21	1%
Replace	21	1%
Unable to obtain readings	20	0.9%
Display or visual feedback problem	17	0.8%

Questions about adaptor, stopcock, manifold, fitting, cardiopulmonary bypass reports

What is product code DTL?

FDA's classification code for "Adaptor, stopcock, manifold, fitting, 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?

2,159 reports through August 2026, 131 of them in the latest 12 months.

Which brands appear most often?

Copilot (226), Copilot Bleedback Control Valve (215), Merit Custom Kit (78), Boston Scientific (63) and Navilyst Medical (36). 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.