Device brand name · Syringe balloon inflation

Encore Balloon Catheter Inflation Device: medical device reports filed with FDA

323 reports name it, 2010–2018. Manufacturer given most often on reports: Boston Scientific - Cork. Product code MAV.

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.

323
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; 99.7%
classified as malfunction: 97% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

323 medical device reports received by FDA name the brand "Encore Balloon Catheter Inflation Device" (syringe balloon inflation); the manufacturer given most often on reports is Boston Scientific - Cork; received from March 2010 to August 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (99.7%) and injury (0.3%); across all syringe, balloon inflation reports (product code MAV) death is recorded in 0.2% and malfunction in 97%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device packaging compromised (25.1%), display or visual feedback problem (24.5%) and tear, rip or hole in device packaging (13%). The patient problems coded most often are no patient involvement and bradycardia. 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 Encore Balloon Catheter Inflation Device was received in the five years to August 2026; the latest was received in August 2018.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.3%1

Malfunction99.7%322

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%323

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 3,685 reports carrying product code MAV. 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
Device packaging compromised	81	25.1%	3%
Display or visual feedback problem	79	24.5%	9.4%
Tear, rip or hole in device packaging	42	13%	1.7%
Device contamination with chemical or other material	40	12.4%	3.3%
Device damaged prior to usethe device was damaged before use	23	7.1%	0.7%
Unable to obtain readings	20	6.2%	2.3%
Inflation problem	15	4.6%	3.7%
Incorrect measurementthe device measured wrongly	8	2.5%	5.6%
Delivered as unsterile product	5	1.5%	0.1%
Sticking	5	1.5%	0.7%
Breakthe device broke	4	1.2%	7.8%
Crackthe device cracked	2	0.6%	0.5%
Detachment of device component	2	0.6%	0.7%
Detachment of device or device componentpart of the device came off	2	0.6%	0.4%
Failure to zero	2	0.6%	0.1%
No display/image	2	0.6%	0.8%
Air leak	1	0.3%	0.5%
Contamination	1	0.3%	0.5%
Decrease in pressure	1	0.3%	0.1%
Defective devicethe device was defective	1	0.3%	0.4%

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	141	43.7%
Bradycardiaslow heart rate	1	0.3%

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

In context

Measure	Encore Balloon Catheter Inflation Device	Product code MAV	All MAUDE reports
Reports	323	3,685	26,136,888
Share of that pool	—	8.8%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	0.3%	2.5%	36.2%
Classified as malfunction	99.7%	97%	62.3%
Filed by the manufacturer	100%	98%	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 MAV

Brand	Reports	Latest 12 months	Classified as death
20/30 Priority Pack Indeflator	571	0	0%
Indeflator	356	23	0%
Advantage Balloon Catheter Inflation Device	288	0	0.3%
20/30 Priority Pack W/Copilot	275	0	0%
20/30 Priority Pack Accessory Kit	157	0	0%
Boston Scientific	580	5	3.3%
Medex	202	8	0%
Polarcath	164	0	3.7%

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 Encore Balloon Catheter Inflation Device reports

How many FDA reports name Encore Balloon Catheter Inflation Device?

323 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 (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device packaging compromised (25.1%), display or visual feedback problem (24.5%), tear, rip or hole in device packaging (13%), device contamination with chemical or other material (12.4%) and device damaged prior to use (7.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Encore Balloon Catheter Inflation Device 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.