Syringe, balloon inflation: medical device reports filed with FDA

3,685 reports carry this product code, 1994–2026; 9 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.

3,685
reports with this product code: 0% of all MAUDE reports; 71
reports, 12 months to August 2026: 259 in the 12 months before; 97%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MAV is FDA's classification for "Syringe, balloon inflation" (cardiovascular panel), a class 2 device. 3,685 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

71 reports arrived in the 12 months to August 2026, down 73% from 259 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 (97%), injury (2.5%) and death (0.2%). 9 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
20/30 Priority Pack Indeflator	571	0	0%	99.5%
Indeflator	333	23	0%	99.7%
Encore Balloon Catheter Inflation Device	323	0	0%	99.7%
Advantage Balloon Catheter Inflation Device	288	0	0.3%	97.2%
20/30 Priority Pack W/Copilot	275	0	0%	98.9%
20/30 Priority Pack Accessory Kit	157	0	0%	98.1%
Boston Scientific	7	5	3.3%	55%
Medex	2	8	0%	81.7%
Polarcath	1	0	3.7%	34.1%

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
Abbott Vascular	1,037	28.1%
Boston Scientific - Cork	822	22.3%
Av-Temecula-Ct	241	6.5%
Merit Medical Systems	56	1.5%
Boston Scientific - Costa Rica Coyol	33	0.9%
Bard Peripheral Vascular	27	0.7%
Abbott Vascular-Cardiac Therapies	11	0.3%
Gyrus Acmi	10	0.3%
Medtronic	9	0.2%
Medex	8	0.2%
Liebel-Flarsheim	1	0%
Medtronic Vascular	1	0%

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

Death0.2%8

Injury2.5%92

Malfunction97%3,575

Other0.1%4

Not given0.2%6

Who filed

Manufacturer report98%3,610

Voluntary report0.8%29

User facility report0%0

Distributor report0%0

Not given1.2%46

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	1,338	36.3%
Display or visual feedback problem	345	9.4%
Breakthe device broke	287	7.8%
Loose or intermittent connection	219	5.9%
Incorrect measurementthe device measured wrongly	208	5.6%
Device damaged by another device	160	4.3%
Inflation problem	138	3.7%
Deflation problem	132	3.6%
Device contamination with chemical or other material	123	3.3%
Device packaging compromised	109	3%
Inaccurate information	108	2.9%
Replace	99	2.7%
Unable to obtain readings	85	2.3%
Tear, rip or hole in device packaging	63	1.7%
Incorrect, inadequate or imprecise result or readings	57	1.5%
Physical resistance/sticking	53	1.4%
Device issuea problem with the device	48	1.3%
Defective component	38	1%
Other (for use when an appropriate device code cannot be identified)	35	0.9%
Packaging problem	32	0.9%

Questions about syringe, balloon inflation reports

What is product code MAV?

FDA's classification code for "Syringe, balloon inflation", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,685 reports through August 2026, 71 of them in the latest 12 months.

Which brands appear most often?

20/30 Priority Pack Indeflator (571), Indeflator (333), Encore Balloon Catheter Inflation Device (323), Advantage Balloon Catheter Inflation Device (288) and 20/30 Priority Pack W/Copilot (275). 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.