Device brand name · Convenience tubing pack

Cardiovascular Procedure Kit: medical device reports filed with FDA

553 reports name it, 1999–2015. Manufacturer given most often on reports: Terumo Cardiovascular Systems. Product code OEZ.

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.

553
device reports naming the brand: 0% of all MAUDE reports · about 20 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 82.6%
classified as malfunction: 86.4% across the product code; 1.3%
classified as death, as reported: 7 reports · not verified by FDA

FDA's MAUDE database holds 553 reports that name the brand "Cardiovascular Procedure Kit" (convenience tubing pack), received between February 1999 and July 2015; the manufacturer given most often on reports is Terumo Cardiovascular Systems. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (82.6%), injury (9.2%) and death (1.3%); across all cardiovascular procedure kit reports (product code OEZ) death is recorded in 1.3% and malfunction in 86.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are leak/splash (32.2%), disconnection (8.9%) and out-of-box failure (8.7%). The patient problems coded most often are no patient involvement, blood loss and death. 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."

Reports by month, five years

No report naming Cardiovascular Procedure Kit was received in the five years to August 2026; the latest was received in July 2015.

By year received

Event type and report source

Event type, as classified on the report

Death1.3%7

Injury9.2%51

Malfunction82.6%457

Other0.9%5

Not given6%33

Who filed the report

Manufacturer report99.3%549

Voluntary report0.2%1

User facility report0%0

Distributor report0%0

Not given0.5%3

Grey bar: all 1,350 reports carrying product code OEZ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Leak/splashthe device leaked	178	32.2%	14.1%
Disconnection	49	8.9%	5.5%
Out-of-box failure	48	8.7%	3.3%
Kinkedthe tube or line kinked	42	7.6%	3.1%
Fluid/blood leak	37	6.7%	7.3%
Partial blockage	26	4.7%	1.9%
Flare or flash	24	4.3%	1.6%
Product quality problem	23	4.2%	2.4%
Fitting problem	17	3.1%	1.3%
Air leak	14	2.5%	3.2%
Crackthe device cracked	14	2.5%	3%
Device contamination with chemical or other material	11	2%	2.2%
Loose or intermittent connection	11	2%	3.5%
Replace	11	2%	0%
Material opacification	10	1.8%	0.6%
Device operates differently than expectedthe device behaved unexpectedly	8	1.4%	0.5%
Misassembled	8	1.4%	0.5%
Device issuea problem with the device	6	1.1%	0.1%
Incorrect device or component shipped	6	1.1%	0%
Material separation	6	1.1%	1.5%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	293	53%
Blood loss	114	20.6%
Deaththe patient died; cause not stated by this term	6	1.1%
Air embolism	1	0.2%
Bradycardiaslow heart rate	1	0.2%
Coagulation disorder	1	0.2%
Exsanguination	1	0.2%
Hemorrhage/blood loss/bleeding	1	0.2%
Low blood pressure/ hypotension	1	0.2%
Low oxygen saturation	1	0.2%
Neurological deficit/dysfunction	1	0.2%
Vascular system (circulation), impaired	1	0.2%
Weakness	1	0.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Cardiovascular Procedure Kit	Product code OEZ	All MAUDE reports
Reports	553	1,350	26,136,888
Share of that pool	—	41%	0%
Classified as death, per 1,000 reports	13	13	9
Classified as injury	9.2%	10.4%	36.2%
Classified as malfunction	82.6%	86.4%	62.3%
Filed by the manufacturer	99.3%	93.5%	94.9%

Shares are of reports, not 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."

Other brands with product code OEZ

Brand	Reports	Latest 12 months	Classified as death
Terumo Cardiovascular Procedure Kit	150	24	0.7%
AngioDynamics	174	14	1.7%
Merit Custom Kit	1,590	13	0.1%
Navilyst Medical	252	0	0.4%
Medline Industries, Inc.	429	100	0.2%
Pressure Monitoring Kit	281	0	0.7%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Cardiovascular Procedure Kit reports

How many FDA reports name Cardiovascular Procedure Kit?

553 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (82.6%), injury (9.2%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

leak/splash (32.2%), disconnection (8.9%), out-of-box failure (8.7%), kinked (7.6%) and fluid/blood leak (6.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.3%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Cardiovascular Procedure Kit was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.