Device brand name · Dilator esophageal
Cre Balloon Dilatation Catheter: medical device reports filed with FDA
154 reports name it, 1998–2018. Manufacturer given most often on reports: Boston Scientific - Cork. Product code KNQ.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 5 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 90.3%
- classified as malfunction
- 90.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
154 medical device reports received by FDA name the brand "Cre Balloon Dilatation Catheter" (dilator esophageal); the manufacturer given most often on reports is Boston Scientific - Cork; received from April 1998 to May 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 (90.3%) and injury (9.7%); across all dilator, esophageal reports (product code KNQ) death is recorded in 0.3% and malfunction in 90.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are burst container or vessel (22.1%), deflation problem (16.2%) and balloon rupture (5.2%). The patient problems coded most often are no patient involvement, perforation and pain. 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 Cre Balloon Dilatation Catheter was received in the five years to August 2026; the latest was received in May 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,261 reports carrying product code KNQ. 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 |
|---|---|---|---|
| Burst container or vessel | 34 | 22.1% | 20.8% |
| Deflation problem | 25 | 16.2% | 6.9% |
| Balloon rupture | 8 | 5.2% | 2.5% |
| Material deformation | 6 | 3.9% | 1.5% |
| Bent | 5 | 3.2% | 1.1% |
| Difficult to removethe device was hard to remove | 5 | 3.2% | 4.4% |
| Torn material | 5 | 3.2% | 0.4% |
| Hole in material | 4 | 2.6% | 4.4% |
| Inflation problem | 4 | 2.6% | 4.8% |
| Detachment of device component | 3 | 1.9% | 2.9% |
| Detachment of device or device componentpart of the device came off | 2 | 1.3% | 1.6% |
| Leak/splashthe device leaked | 2 | 1.3% | 6.5% |
| Material too rigid or stiff | 2 | 1.3% | 0% |
| Balloon burst | 1 | 0.6% | 2.5% |
| Breakthe device broke | 1 | 0.6% | 3.1% |
| Failure to fold | 1 | 0.6% | 0% |
| Foreign material | 1 | 0.6% | 0.1% |
| Incorrect device or component shipped | 1 | 0.6% | 0% |
| Kinkedthe tube or line kinked | 1 | 0.6% | 0.8% |
| Loss of or failure to bond | 1 | 0.6% | 0.1% |
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 | 4 | 2.6% |
| Perforation | 3 | 1.9% |
| Painpain, site not specified | 2 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cre Balloon Dilatation Catheter | Product code KNQ | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 5,261 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 9.7% | 8.6% | 36.2% |
| Classified as malfunction | 90.3% | 90.6% | 62.3% |
| Filed by the manufacturer | 100% | 95.1% | 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 KNQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CRE Fixed Wire | 952 | 152 | 0% |
| Hercules 3 Stage Wireguided Balloon Esophageal-Pyloric-Colonic | 644 | 46 | 0% |
| Xxl Esophageal | 639 | 14 | 0.2% |
| Hercules 3 Stage Balloon Esophageal | 454 | 7 | 0% |
| Cre Pro Gi | 344 | 62 | 0% |
| CRE Wireguided | 718 | 56 | 0.3% |
| Quantum Ttc Esophageal Balloon Dilator | 218 | 0 | 0% |
| XXL? Vascular | 220 | 8 | 0.9% |
| Captura Serrated Forceps With Spike | 223 | 0 | 0% |
| Amplatz Super Stiff Guidewire | 403 | 0 | 3% |
| Balloon | 330 | 48 | 0.3% |
| Boston Scientific | 580 | 5 | 3.3% |
| Conmed | 900 | 89 | 0.2% |
| Cre Pro | 985 | 341 | 0.1% |
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." 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 Cre Balloon Dilatation Catheter reports
How many FDA reports name Cre Balloon Dilatation Catheter?
154 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 (90.3%) and injury (9.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
burst container or vessel (22.1%), deflation problem (16.2%), balloon rupture (5.2%), material deformation (3.9%) and bent (3.2%). 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 Cre Balloon Dilatation Catheter 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.